regulatory affairs manager

Abbott

<div>
 <strong>
  Primary Job Function :
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Supports affiliates in the execution of registration plans, ensuring timely and compliant submissions across EM markets including but not limited to Biosimilars
  </li>
  <li>
   Monitors progress of product registrations and maintains oversight of regional regulatory timelines and requirements.
  </li>
  <li>
   Provides coordination and operational support to local Regulatory Affairs teams to ensure alignment and regulatory compliance.
  </li>
  <li>
   Support collecting and interpreting the guidelines related to Biosimilars
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Core Job Responsibilities :
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Product registrations /Submissions
  </li>
  <li>
   Coordinate the execution of the regulatory strategies ensuring close monitoring and follow up with the affiliates and timely reporting.
  </li>
  <li>
   Relationships &amp; Cross Functional teamwork
  </li>
  <li>
   Ensure good collaboration and relationship with the regulatory teams in the affiliate and the emerging markets
  </li>
  <li>
   Supports the internal stakeholders for any regulatory affairs ad-hoc request
  </li>
  <li>
   Affiliate Coordination
  </li>
  <li>
   Maintains effective working relationships with local RA teams and global RA teams
  </li>
  <li>
   Ensure proper coordination between the RA affiliates and stakeholders in the defined areas
  </li>
  <li>
   Compliance across lifecycles
  </li>
  <li>
   Supports the coordination of new product registration activities ensuring alignment with regulatory requirements and business timelines.
  </li>
  <li>
   Provides day‑to‑day support to ensure products remain compliant throughout their lifecycle.
  </li>
  <li>
   Regulatory Operations
  </li>
  <li>
   Coordinates the preparation and submission of registration dossiers, variations, renewals, and clinical trial applications, ensuring timely execution
  </li>
  <li>
   Monitors timelines for key submissions (e.g., new registrations, variations, CCDS updates, PSURs, license renewals) and supports affiliates to ensure continuity of product availability.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Accountability/Scope :
  <br/>
  <br/>
 </strong>
 Accountable that the business remains compliance with all regulatory aspects (local and Abbott policy) and all regulatory agency submission materials are within timeliness, accuracy, comprehensiveness and compliance with regulatory standards.
 <br/>
 <br/>
 <strong>
  Minimum Education :
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s Degree of Pharmacy or
  </li>
  <li>
   Bachelor&rsquo;s Degree of Life Science or
  </li>
  <li>
   Bachelor&rsquo;s Degree of Science
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Experience/Training Required :
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   At least 5 years of working experience in similar roles
  </li>
  <li>
   Understanding of regulatory affairs in pharmaceutical environment, experience interfacing with government and regulatory agencies and proven skills in developing and implementing successful regulatory strategies. Strong communication skills to effectively present regulatory information to management and government agencies
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Management Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Uses resources effectively and efficiently.
  </li>
  <li>
   Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.
  </li>
  <li>
   Maintain and operate within budget.
  </li>
  <li>
   Capable of analyzing and investigating issues and problem solving.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Communication Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Effectively practices listening skills before responding to issues.
  </li>
  <li>
   Effectively writes, presents and communicates information to internal and external clients, including divisional management.
  </li>
  <li>
   Effective negotiation skills.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills
  <br/>
  <br/>
 </strong>
 <strong>
  Total Quality Management (TQM) Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Demonstrates the ability to exercise good judgment on regulatory and compliance issues.
  </li>
  <li>
   Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.
  </li>
 </ul>
</div>


EM Regulatory Affairs Manager (Biosimilar)

Sandoz Egypt

<div>
 <ul>
  <li>
   Responsible for implementing regulatory strategy and managing operational activities for the assigned SSA countries.
  </li>
  <li>
   Responsible to coordinate and follow up with all responsible distributors and local representatives and scientific offices on the geographical region of SSA.
  </li>
  <li>
   Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for the assigned SSA countries.
  </li>
  <li>
   Find synergies between countries, align with different stakeholders to obtain approvals and unlock struggles with appointments and long timelines.
  </li>
  <li>
   Partners with regions align regulatory strategy in order to fulfil business objectives -Implements Regulatory Functional Plan across the assigned SSA countries.
  </li>
  <li>
   Determines requirements and sets objectives for Health Authority interactions .
  </li>
  <li>
   Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
  </li>
  <li>
   Develops and implements plans for timely response to Health Authority requests and coordinates responses.
  </li>
  <li>
   Drives coordination, planning, and submission of dossiers in the assigned SSA countries.
  </li>
  <li>
   Review of global dossier summary documents.
  </li>
  <li>
   Develops and implements plans to avoid/minimize clock stops during submission review.
  </li>
  <li>
   Responsible to maintain KPIs of all compliance and safety metrics from regulatory perspective.
  </li>
  <li>
   Responsible for facilitating timely submission and approval of dossier with Health Authority under the guidance of the global and regional RA
  </li>
  <li>
   Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Key Performance Indicators
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
  </li>
  <li>
   Successful management of local distributors and scientific offices in countries and ensure KPI monitoring and stakeholder management.
  </li>
  <li>
   Identification of main Health Authority issues
  </li>
  <li>
   Participation in relevant regulatory Boards leading to valuable input from these Boards.
  </li>
  <li>
   Successful Participation in Health Authority interactions to achieve business objectives.
  </li>
  <li>
   Adherence to Sandoz policy and guidelines
  </li>
  <li>
   Project &amp; stakeholder feedback
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in pharmacy or related field
  </li>
  <li>
   7+ years of relevant regulatory experience with 3+ years in managerial role within pharmaceutical industry
  </li>
  <li>
   Experience in regulatory affairs in the region of SSA and working the distributors and country scientific offices.
  </li>
  <li>
   Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
  </li>
  <li>
   Experience in interacting with government authorities
  </li>
  <li>
   Strong knowledge of labeling requirements and GxP documentations
  </li>
  <li>
   Attention to detail, organizational skills and ability to work with documentation
  </li>
  <li>
   Fluent in English and Arabic . French is a plus.
  </li>
 </ul>
</div>


Regulatory Affairs Senior Manager, Sub‑Saharan Africa

Amgen

<div><div>Egypt - Cairo
<div>JOB ID: R-251623 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jul. 29, 2026 CATEGORY: Regulatory
</div></div><div><div><p><b>HOW MIGHT YOU DEFY IMAGINATION?</b></p><p>
If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.</p><p><b>
SENIOR ASSOCIATE REGULATORY AFFAIRS</b></p><p><b>
WHAT YOU WILL DO</b></p><p>
In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.</p><ul><li>
Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</li><li>
Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements</li><li>
Manufacturing site registration and license maintenance</li><li>
Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided</li><li>
Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals</li><li>
Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications</li><li>
Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers</li><li>
Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning</li><li>
Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance</li><li>
Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans</li><li>
Accountable for solving all supply issues related to regulatory activities.</li><li>
To provide regulatory intelligence</li><li>
Ensure compliance with company's SOPs and working practices for Good Regulatory Practice</li><li>
Management of documentation archiving and record keeping according to SOP and local legislation</li><li>
Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies</li><li>
Collate, distribute, exchange and archive regulatory information with colleagues across the business</li><li>
Participate in regulatory and affiliate process improvements initiatives</li><li>
Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice</li></ul><p><b>
BE PART OF OUR TEAM</b></p><p>
Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.</p><p></p><p><b>
WHAT WE EXPECT OF YOU</b></p><p>
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:</p><ul><li>
Pharmacy Bachelor&rsquo;s degree</li><li>
2-3 years of directly related experience in regulatory affairs (ELI markets)</li><li>
Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets</li><li>
Strong communication skills both verbal and written</li><li>
Organizational skills &amp; developing regulatory project management skills</li></ul><p><b>
Thrive</b></p><p></p><p><b>
What you can expect of us</b></p><p></p><p>
As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.</p><ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul><p></p><p><b>
 for a career that defies imagination</b></p><p></p><p>
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.</p><p><b>
careers.amgen.com</b></p><p></p><p>
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</p></div></div></div><p></p>

Senior Associate Regulatory Affairs

FMC Corporation

<div><p><b>About us</b></p><p>
We, FMC Agricultural Solutions, provide innovative crop protection solutions to growers around the world. Thanks to the commitment of our 6,500 employees, we are one of the six largest crop protection manufacturers in the world.</p><p></p><p>
For more information, please visit www.FMC.com.</p><p></p><p>
We are looking for a <b>Regulatory &amp; Development Specialist - Turkey (Remote)
</b></p><p></p><p>The role is responsible for supporting the registration and development of crop protection products in compliance with Turkish regulations. This includes coordinating product development activities, preparing regulatory submissions, and working closely with government authorities, research partners, and internal teams to ensure successful product registrations and market support. The position requires 5+ years of regulatory and product development experience, strong project management and communication skills, and willingness to travel within Turkey.</p><p></p><p><b>
Key Responsibilities</b></p><ul><li>
Manage product development projects, including new product development and label extension initiatives.</li><li>
Plan, coordinate, and monitor field trials with research organizations, distributors, and internal stakeholders.</li><li>
Ensure accurate recording, analysis, and reporting of trial data to regional technical and regulatory teams.</li><li>
Provide technical support through product training, customer events, and knowledge sharing.</li><li>
Prepare and support regulatory submissions for new registrations, renewals, label extensions, and other changes.</li><li>
Monitor registration progress and liaise with regulatory authorities to ensure timely approvals.</li><li>
Maintain regulatory databases, project documentation, and filing systems.</li><li>
Coordinate label approvals, regulatory documentation, sample logistics, and follow-up actions.</li><li>
Collaborate with internal and external stakeholders while ensuring compliance with company procedures and local regulations.</li></ul><p></p><p><b>
Your qualification:</b></p><ul><li>
Bachelor's degree in Agricultural Engineering; MSc or PhD.</li><li>
Minimum 5 years' experience in crop protection product development and registration</li><li>
Strong knowledge of Turkish pesticide and fertilizer registration legislation and Ministry of Agriculture procedures.</li><li>
Experience preparing regulatory dossiers and managing product development projects.</li><li>
Proficiency with regulatory management systems (e.g., Veeva Vault) and MS Office.</li><li>
Strong project management, organizational, and communication skills.</li><li>
Fluent in English.</li><li>
Willingness to travel within Turkey.</li></ul><p></p><p><b>
Are You Ready to Make an Impact?</b></p><p>
If you're passionate about making a difference and share our values of diversity, collaboration, and quality, we encourage you to submit your application today. We eagerly await hearing from you!</p></div><p></p>

Regulatory & Development Specialist

CCL Pharmaceuticals

<div>
 <p>
  <strong>
   Who We Are
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  CCL Pharmaceuticals is a global life sciences company committed to improving access to trusted healthcare. With a presence in more than 20 countries and six decades of impact, we work to enable Healthy, Happy Lives through science-backed solutions.
 </p>
 <p>
  Our portfolio spans diabetes, cardiovascular, neurology, psychiatry, urology, oncology, immunology, biosimilars, cough and cold, vitamins, minerals, and supplements segments, to name a few. Across all markets, over 3,000 people combine scientific expertise, local insight, and a shared purpose to enhance how individuals live, heal, and care for themselves.
 </p>
 <p>
  Joining CCL Pharmaceuticals means stepping into a collaborative, mission-driven environment where your growth matters as much as your contribution. We enable you to learn, lead, and innovate through every stage of your journey, because the impact we make in healthcare begins with how you Grow with CCL.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What You'll Do
  </strong>
 </p>
 <p>
  In this role, you will lead the planning, execution, and continuous improvement of qualification and validation activities across manufacturing, utilities, facilities, equipment, cleaning processes, analytical methods, and production processes in accordance with the Validation Master Plan (VMP) and global regulatory requirements. You will oversee the development and maintenance the Validation Master Plan, review validation protocols and reports, coordinate qualification activities with Engineering and Manufacturing teams, administer Product Quality Reviews (PQRs), support regulatory inspections and new product registrations, and drive continuous improvements that strengthen compliance, inspection readiness, and operational excellence.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   You Are Good At
  </strong>
 </p>
 <ul>
  <li>
   Leading qualification and validation programs across manufacturing operations.
  </li>
  <li>
   Developing and executing Validation Master Plans (VMP).
  </li>
  <li>
   Reviewing validation protocols, reports, and technical documentation with accuracy and attention to detail.
  </li>
  <li>
   Managing cross-functional validation projects and balancing competing priorities.
  </li>
  <li>
   Administering Product Quality Reviews (PQRs) and driving timely follow-up actions.
  </li>
  <li>
   Interpreting GMP, PIC/S, and regulatory requirements to ensure compliant validation practices.
  </li>
  <li>
   Supporting regulatory inspections and validation documentation for product registrations.
  </li>
  <li>
   Building collaborative relationships across Manufacturing, Engineering, Quality Control, and Regulatory Affairs functions.
  </li>
  <li>
   Applying analytical thinking and structured problem-solving to quality and validation challenges.
  </li>
  <li>
   Driving continuous improvement across quality and validation systems.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What You'll Bring
  </strong>
 </p>
 <ul>
  <li>
   Pharm.D, or Master's in Chemistry from and HEC recognized university.
  </li>
  <li>
   7-8 years of experience in Qualification, Validation, or Quality Assurance within a pharmaceutical manufacturing organization.
  </li>
  <li>
   Strong expertise in Validation Master Planning, Process Validation, Cleaning Validation, Analytical Method Validation, Equipment Qualification, Utility Qualification, and Facility Qualification.
  </li>
  <li>
   Sound knowledge of Product Quality Reviews (PQR), cGMP, PIC/S, and international regulatory requirements.
  </li>
  <li>
   Experience supporting regulatory inspections and validation documentation for new product registrations.
  </li>
  <li>
   Proficiency in Microsoft Office and documentation management systems.
  </li>
  <li>
   Strong analytical, leadership, presentation, communication, and stakeholder management skills.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Who You'll Work With
  </strong>
 </p>
 <p>
  This role reports directly to the General Manager Quality Assurance and works closely with teams across Quality Assurance, Manufacturing, Engineering, Quality Control, Regulatory Affairs, Supply Chain, and other operational functions to strengthen validation excellence, regulatory compliance, and quality systems across the organization.
 </p>
 <p>
  <br/>
 </p>
 <p>
  The culture you'll experience is shaped by three principles:
 </p>
 <ul>
  <li>
   Transparency in communication, goals, and decision-making.
  </li>
  <li>
   Inclusion in how people are developed, supported, and empowered.
  </li>
  <li>
   Performance-driven mindset that links quality excellence to business outcomes.
  </li>
 </ul>
 <p>
  Our values guide how we work every day:
 </p>
 <ul>
  <li>
   Integrity First &ndash; Doing the right thing, consistently.
  </li>
  <li>
   Collaborate to Win &ndash; Building success together.
  </li>
  <li>
   Passion to Grow &ndash; Continuous learning and development.
  </li>
  <li>
   Innovation to Excel &ndash; Improving impact through better ideas.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What We Offer
  </strong>
 </p>
 <p>
  Opportunity to lead qualification and validation initiatives within a globally growing pharmaceutical organization.
 </p>
 <p>
  Exposure to international regulatory standards, validation practices, and quality systems.
 </p>
 <p>
  Cross-functional leadership opportunities across Manufacturing, Engineering, Quality Control, and Regulatory Affairs.
 </p>
 <p>
  A collaborative workplace focused on innovation, compliance, and continuous improvement.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Important Notice
  </strong>
 </p>
 <p>
  CCL Pharmaceuticals is an equal opportunity employer. All applicants are considered based on merit, qualifications, and organizational need. We are committed to fostering an inclusive environment that respects diverse backgrounds, perspectives, and experiences.
 </p>
 <p>
  <br/>
 </p>
 <p>
  For more information about this opportunity and to apply, please visit our website: Sign In - Applicant Portal
 </p>
</div>


Manager Quality Assurance

Hueman People Solutions

<div><div><div><p>The Executive Recruiting Partner &ndash; Life Sciences will be responsible for delivering top talent across highly specialized roles within the pharmaceutical and biotechnology sectors. This position requires deep expertise in full-cycle recruitment with a strong focus on sourcing and engaging candidates in niche areas such as commercial, medical affairs, clinical, and scientific functions.</p>
</div><div><p><b>Accountabilities</b></p>
</div><div><ul><li><p>Strategic Recruitment, Sourcing and Candidate Management &ndash; 80%</p></li>
</ul></div><div><ul><li><p>Client &amp; Hiring Manager Partnership &ndash; 20%</p></li>
</ul></div><div><p><b>Key Responsibilities</b></p>
</div><div><ul><li><p>Develop and execute targeted sourcing strategies to attract executive and specialized talent across life sciences functions</p></li>
</ul></div><div><ul><li><p>Build and manage candidate pipelines for commercial, medical affairs, clinical, regulatory, and scientific leadership roles</p></li>
</ul></div><div><ul><li><p>Assess candidate qualifications and alignment with client requirements, ensuring only the strongest talent is presented</p></li>
</ul></div><div><ul><li><p>Serve as a trusted advisor to hiring managers, providing insights on market trends, talent availability, and competitive intelligence</p></li>
</ul></div><div><ul><li><p>Partner with clients to manage expectations throughout the recruitment process and guide them through selection and hiring decisions</p></li>
</ul></div><div><ul><li><p>Track and report key recruitment metrics such as time-to-fill, candidate pipeline activity, and offer acceptance rates</p></li>
</ul></div><div><ul><li><p>Maintain the highest standards of integrity, professionalism, and confidentiality when working with clients and candidates</p></li>
</ul></div><div><p><b>Requirements</b></p>
</div><div><ul><li><p>Bachelor&rsquo;s degree preferred, or equivalent work experience</p></li>
</ul></div><div><ul><li><p>7+ years of successful full-cycle recruitment experience, with proven success recruiting across life sciences organizations.</p></li>
</ul></div><div><ul><li><p>Demonstrated expertise recruiting for clinical, regulatory, medical affairs, research &amp; development, quality, pharmacovigilance, and other specialized functions within pharmaceutical and biotechnology organizations required.</p></li>
</ul></div><div><ul><li><p>Experience recruiting for corporate and shared services functions preferred.</p></li>
</ul></div></div><div><div><ul><li><p>Strong sourcing skills and ability to identify passive talent in highly competitive markets</p></li>
</ul></div><div><ul><li><p>Proficiency with Microsoft Office (Outlook, Excel, Word) and applicant tracking systems (ATS)</p></li>
</ul></div><div><ul><li><p>Excellent communication, relationship management, and consultative skills</p></li>
</ul></div><div><ul><li><p>Strong integrity, accountability, and adaptability in a fast-paced environment</p></li>
</ul></div><div><ul><li><p>Ability to travel for onsite client support, as needed</p></li><br>
</ul></div><p></p><div><p><b>Compensation &amp; Benefits</b></p>
</div><div><ul><li><p>Paid time off (PTO)</p></li>
</ul></div><div><ul><li><p>Health, dental, vision, and life insurance</p></li>
</ul></div><div><ul><li><p>Traditional and Roth 401(k) options with company match</p></li>
</ul></div><div><ul><li><p>Leadership development and career advancement opportunities</p></li>
</ul></div><div><ul><li><p>Community service events</p></li>
</ul></div><div><ul><li><p>Wellness and mental health support</p></li>
</ul></div><div><ul><li><p>A fun work environment that emphasizes togetherness, diversity, and collaboration</p></li><br>
</ul></div><p></p><div><p><b>Physical Requirements:</b></p>
</div><div><ul><li><p>Prolonged periods of sitting at a desk and working on a computer.</p></li>
</ul></div><div><ul><li><p>Ability to provide a stable internet connection and a quiet, professional work environment when working from home.</p></li>
</ul></div><div><ul><li><p>Candidates hired for this position must pass onboarding and credentialing requirements set by both Hueman and the client.</p></li>
</ul></div><div><p>Applicants requiring a reasonable accommodation to participate in the hiring process may contact recruiting@hueman.com</p>
</div><div><p><b>Equal Opportunity Employer</b></p>
</div><div><p>Hueman is an Equal Opportunity Employer. We are committed to increasing workforce diversity, fostering inclusive environments, and sustaining those efforts through equitable practices not only across our own businesses but across our partners' as well. Hueman provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected by applicable federal, state, or local law. This mission is guided by our core values of excellence, trust, change, service, and teamwork.</p></div></div></div>

Executive Recruiting Partner, Life Sciences

CoorsTek, Inc.

<div>
 It's exciting to work for a company that makes the world measurably better.
 <br/>
 <br/>
 We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing.
 <br/>
 <br/>
 <strong>
  Job Title
  <br/>
  <br/>
 </strong>
 Quality Assurance Engineer I
 <br/>
 <br/>
 CoorsTek is seeking a Quality Assurance Engineer I to join the Bioceramics Quality team in Grand Junction, CO. This is a key growth-enabling role responsible for partnering with medical device customers on regulatory and product qualification submissions, supporting expansion into new geographies and customer programs. The ideal candidate brings a background in medical device quality or regulatory affairs and is passionate about solving complex technical challenges at the intersection of advanced materials and patient care.
 <br/>
 <br/>
 Key Responsibilities
 <br/>
 <br/>
 <br/>
 <ul>
  <li>
   Serve as the primary quality engineering liaison for internal and external medical device customer programs, supporting regulatory and product technical submissions (FDA 21 CFR 820, ISO 13485).
  </li>
  <li>
   Partner with customers to complete qualification activities for CoorsTek Bioceramics as a supplier, including process flow documentation, risk documentation, measurement system comparisons, and material property testing.
  </li>
  <li>
   Design, install, and continually evaluate quality assurance and control methods and systems.
  </li>
  <li>
   Develop standards, procedures, and work instructions to provide quality guidance and facilitate training.
  </li>
  <li>
   Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct and support internal and external audits.
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   Develop sampling plans and statistical methods for manufacturing and inspection; determine control points and charting methods.
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   Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
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   Develop, generate, and analyze reports and returned products to identify trends and facilitate corrective action and quality improvements.
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   Interface with engineering and production teams to design fixtures and processes that ensure measurement system effectiveness.
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 What Makes This Role Exciting
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   Key growth enabler for the Bioceramics business &mdash; you&rsquo;ll partner directly with new customers to expand geographic footprint and support increasing production demand.
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   Forefront of new product and material development &mdash; solving novel technical challenges in advanced materials used in medical applications.
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   High visibility role with direct impact on CoorsTek&rsquo;s ability to serve medical device OEMs and grow its position as a critical supplier.
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  </li>
 </ul>
 <strong>
  Requirements
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 </strong>
 <strong>
  Education
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 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in a related technical field; Professional Engineer (PE) and/or ASQ Certified Quality Engineer (CQE) a plus.
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  </li>
 </ul>
 <strong>
  Experience
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 </strong>
 <ul>
  <li>
   Minimum 3 years&rsquo; relevant experience within the medical device industry with a focus on quality or regulatory product submissions; manufacturing experience preferred.
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   Background in medical device design, regulatory affairs, or quality management strongly preferred; ceramics or advanced materials experience a plus but not required.
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   Demonstrated experience managing the technical aspects of qualifying medical devices for patient use, including recommending ISO standards, testing processes, and design controls.
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 </ul>
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  Technical Skills &amp; Competencies
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 </strong>
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  <li>
   Working knowledge of medical device regulated quality or regulatory standards (FDA 21 CFR 820, ISO 13485).
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   Ability to recommend and implement ISO standards, testing processes, design controls, and regulatory affairs requirements.
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   In-depth knowledge of statistical techniques (SPC, DOE, capability studies); ability to identify, analyze, and define solutions for continuous improvement.
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   Advanced math skills; ability to interpret and communicate technical data in mathematical or diagram form.
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   Excellent communication skills; ability to read, analyze, and present complex technical information to diverse audiences.
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   Effective collaborator across engineering, production, and customer-facing teams.
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   CMM/fixture interface experience a plus, but not required.
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  </li>
 </ul>
 <strong>
  Target Hiring Range
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 </strong>
 : USD 75,000.00 - USD 91,000.00
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 Actual compensation is commensurate with experience, skills and education. CoorsTek strives to give all qualified applicants equal opportunity and to make selection decisions on job related factors. Do not provide any information on the application which will indicate your race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, pregnancy, genetic information, veteran status, or any other status protected by law or regulation.
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 If you like working for a company that makes a real difference in the world, you'll enjoy your career with us!
</div>


Quality Assurance Engineer I

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