regulatory affairs specialist

Abbott

<div>
 
 Primary Job Function :
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Core Job Responsibilities :
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 Position Accountability/Scope :
 
 
 
 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.
 
 
 
 Minimum Education :
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Minimum Experience/Training Required :
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Management Skills
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 Communication Skills
 
 
 
 <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.
 
 
 </li>
 </ul>
 
 Skills
 
 
 
 
 Total Quality Management (TQM) Skills
 
 
 
 <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)

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>HOW MIGHT YOU DEFY IMAGINATION?
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.
SENIOR ASSOCIATE REGULATORY AFFAIRS
WHAT YOU WILL DO
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.<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>
BE PART OF OUR TEAM
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.
WHAT WE EXPECT OF YOU
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:<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>
Thrive
What you can expect of us
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.<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>
 for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
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.</div></div></div>

Senior Associate Regulatory Affairs

Pacific Gas and Electric

Requisition ID # 173432
 
Job Category: Government and Regulatory Relations
 Job Level: Individual Contributor
 Business Unit: Customer & Corporate Affairs
 Work Type: Hybrid
 Job Location: Oakland
 
Department Overview
 
Customer & Corporate Affairs (C&CA) brings together the people and capabilities that shape how PG&E serves customers and engages with the communities and policymakers who rely on us. Our organization spans customer experience, communications, local engagement, regulatory strategy and public policy - uniting these functions to support safe, reliable, affordable and clean energy for all.
 
The Regulatory & Rates department within C&CA leads regulatory policy development and implementation, advocacy, and rate design and data analysis, while managing an increasing number of complex regulatory cases and initiatives at the California Public Utilities Commission (CPUC) and the Federal Energy Regulatory Commission (FERC). Regulatory & Rates builds trust and credibility with our regulators and stakeholders to support customers' needs and preferences, delivering value through regulatory policy and achieving operational efficiencies.
 
Position Summary
 
Provides support for the case management, case coordination and related management functions in Regulatory and Rates.
 
This position is hybrid, working from your remote office and your assigned work location based on business need. The assigned work location will be within the PG&E Service Territory.
 
PG&E is providing the salary range that the company in good faith believes it might pay for this position at the time of the job posting. This compensation range is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, specific skills, education, licenses or certifications, experience, market value, geographic location, and internal equity.
 This job is also eligible to participate in PG&E’s discretionary incentive compensation programs.
 
A reasonable salary range is: 
Bay Area Minimum: $75,,000
 Bay Area Maximum: $113,000
 
Job Responsibilities
 <ul>
<li>Performs duties of cNet Administrator (Regulatory Compliance Management Tool), gNet Administrator (Case Management Governance Tool), WebDocs Administrator (Regulatory Records Archive), Guidance Document Administrator, and SharePoint Administrator.</li>
<li>Provides document posting support for WebDocs.</li>
<li>Provides support in identifying, testing and implementing enhancements to tools and applications.</li>
<li>Assists in documenting department processes and procedures for the systems/tools and/or guidance documents.</li>
<li>Prepares and/or coordinates the production of regular or ad hoc metrics and operational reports.</li>
<li>Provides training on systems/tools for new and existing users.</li>
<li>Demonstrates expertise in department and enterprise applications and software in support of department objectives and utilizes this expertise to support clients, including addressing issues and answering questions.</li>
</ul>
Qualifications
 
Minimum: 
<ul>
<li>Bachelors Degree or equivalent experience</li>
<li>Job-related experience, 2 years</li>
</ul>
Desired: 
<ul>
<li>Experience with software, job-related</li>
<li>Experience in regulatory environment</li>
<li>Experience with Microsoft 365 product family of productivity, collaboration, and cloud-based software and services (advanced level)</li>
<li>Knowledge, Skills, Abilities (Desired)</li>
</ul>
o Ability to pay attention to details, be careful about details and thorough in completing work tasks
 o Ability to read and understand information and ideas presented through written material as need to perform at the job level
 o Competency in building partnerships and working collaboratively with others to meet shared objectives
 o Competency in making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems
 o Competency in building strong customer relationships and delivering customer-centric solutions
 o Competency in developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences

Regulatory Support Specialist, Career (Parent Req to 173433 )

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.
 
 
 </li>
 </ul>
 
 Key Performance Indicators
 
 
 
 <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
 
 
 </li>
 </ul>
 
 Minimum Requirements
 
 
 
 <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

Brown University Health

<div><ul><li>Job ID: JR-112254
</li><li>Entity: Rhode Island Hospital
</li><li>Location Name: Rhode Island Hospital
</li><li>City, State: Providence, RI
</li><li>Work Type: FULL TIME
</li><li>Hours Per Week: 40
</li><li>Shift: Day
</li><li>Posted Date: 7/30/2026
</li></ul><div><h2 class="jobSectionHeader">SUMMARY</h2>

The Sr. Research Regulatory Coordinator is responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Sr. Research Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr. Research Regulatory Coordinator will provide support in managing the clinical trials within the department, instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. The Sr. Research Regulatory Coordinator shall work closely with department leadership.

Brown University Health employees are expected to successfully role model the organization&rsquo;s values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:
<ul>
<li>Instill Trust and Value Differences</li>
<li>Patient and Community Focus and Collaborate</li>
</ul><h2 class="jobSectionHeader">RESPONSIBILITIES</h2>

The Sr. Research Regulatory Coordinator is responsible for all duties listed under the Regulatory Coordinator position, such as:
<ul>
<li>Develops protocols with the Principle Investigator and provides recommendations on research plan</li>
<li>Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors</li>
<li>Prepare and maintain study specific regulatory binder(s) and documents</li>
<li>Serves as the regulatory subject matter expert through all phases of a clinical study, including regulatory documents and/or processes related to clinical trials conduct</li>
<li>Initiates and leads special projects, to include process improvement and regulatory training</li>
<li>Ensures proper regulatory compliance in accordance with sponsoring agency requirements</li>
<li>Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines</li>
</ul>
Additionally, the Sr. Research Regulatory Coordinator position will be responsible for the following:
<ul>
<li>Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Manages the preparation of annual reports to the FDA, as necessary. Manages and updates clinical trial/study information located on the clinicaltrials.gov website, as needed</li>
<li>Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI), CV&rsquo;s, MLs, HSP and GCP training</li>
<li>Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses</li>
<li>Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the department&rsquo;s mentorship program</li>
<li>Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems</li>
<li>Compile regulatory-related metrics for use by department leadership</li>
<li>Performs other duties as assigned</li>
</ul><h2 class="jobSectionHeader">MINIMUM QUALIFICATIONS</h2>
<h3 class="jobSectionHeader">BASIC KNOWLEDGE</h3>
<ul><li>Bachelor&rsquo;s degree in health-related or scientific field is required; Master&rsquo;s degree preferred</li>
<li>SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire</li>
<li>Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research</li>
<li>Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Must demonstrate strong leadership and organizational skills</li>
</ul>
Must possess the following skills:
<ul>
<li>Detail-oriented and excellent organizational skills
</li>
<li>Strong self-starter
</li>
<li>Interpersonal skills
</li>
<li>Strong problem-solving skills
</li>
<li>Team-oriented
</li>
<li>Excellent oral and written communication skills
</li>
<li>Proficient in Microsoft Office and in various database applications
</li>
<li>Comprehensive knowledge of FDA guidelines
</li>
<li>Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary
</li>
</ul><h3 class="jobSectionHeader">EXPERIENCE</h3>
<ul><li>3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience</li>
<li>Past experience in federal, state and/or local programmatic regulations compliance</li>
</ul><h2 class="jobSectionHeader">WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS</h2>

This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.
<h2 class="jobSectionHeader">
INDEPENDENT ACTION</h2>

This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies, including, but not limited to study sponsors, local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians, as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently. He/she should be able to answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.
<h2 class="jobSectionHeader">
SUPERVISORY RESPONSIBILITY</h2>

One to three regulatory staff members.
<h2 class="jobSectionHeader">
Pay Range</h2>

$64,480.00-$106,412.80
<h2 class="jobSectionHeader">
Location</h2>

Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903
<h2 class="jobSectionHeader">
Work Type</h2>

M-F 8am-4:30pm
<h2 class="jobSectionHeader">
Work Shift</h2>

Day
<h2 class="jobSectionHeader">
Daily Hours</h2>

8 hours
<h2 class="jobSectionHeader">
Driving Required</h2>

Yes

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.</div></div>

Sr Research Regulatory Coordinator 1

51Talk

<div>
 
 
 About Us
 
 
 
 51Talk, a publicly listed multinational company, is a global leader in online English education, connecting learners with certified teachers for personalized, one-on-one lessons. Established in 2011, we leverage innovative technology to deliver high-quality, affordable language education to students worldwide.
 
 
 
 
 
 
 
 
 Responsibilities:
 
 
 
 
 1. Government Relations Management &amp; Communication
 
 
 <ul>
 <li>
 Establish and maintain long-term, stable cooperative relationships with relevant government departments, including the
 
 Ministry of Education (MOE)
 
 ,
 
 Ministry of Investment (MISA)
 
 ,
 
 Ministry of Communications and Information Technology (MCIT)
 
 , and the
 
 Ministry of Human Resources and Social Development (HRSD)
 
 .
 </li>
 <li>
 Represent the company at government meetings and industry seminars to clearly communicate the company's position and business value.
 </li>
 <li>
 Provide internal updates on government policy trends and offer communication strategies or contingency plans for key issues.
 </li>
 </ul>
 
 
 2. Policy Analysis &amp; Compliance Support
 
 
 <ul>
 <li>
 Continuously track, collect, and analyze Saudi laws, regulations, and policy trends relevant to the company&rsquo;s business (specifically in
 
 education, technology, foreign investment, and data protection
 
 ).
 </li>
 <li>
 Draft policy analysis reports, interpret the impact of policies on business operations, and provide strategic recommendations to management.
 </li>
 <li>
 Ensure that business operations, marketing activities, and products comply with all local Saudi laws and regulatory requirements.
 </li>
 </ul>
 
 
 3. Strategic Project Support
 
 
 <ul>
 <li>
 Assist business departments in designing integration plans for government-led initiatives (such as
 
 educational digitalization and language training
 
 ) to drive cooperation opportunities.
 </li>
 <li>
 Provide guidance and support during government tenders, qualification applications, and licensing processes.
 </li>
 </ul>
 
 
 4. Internal Collaboration &amp; Training
 
 
 <ul>
 <li>
 Act as a Government Affairs expert, providing consultation and training to internal teams (Marketing, Product, Legal, etc.) regarding the Saudi policy environment.
 </li>
 <li>
 Coordinate internal resources to respond efficiently to government inquiries or surveys.
 </li>
 </ul>
 
 
 
 
 
 Job Requirements
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree or higher from a well-known Saudi or top-tier international university. Majors in
 
 Public Policy, International Relations, Law, Business, or Education
 
 are preferred.
 </li>
 <li>
 Min 3+ years of experience in external affairs, working with Saudi government departments, public institutions, multinational corporate government affairs teams, or reputable consulting firms.
 </li>
 <li>
 Experience working with the
 
 Saudi Ministry of Education
 
 or other education/training-related government sectors is highly preferred.
 </li>
 <li>
 Familiarity with the Saudi government structure, decision-making processes, and the policy-making environment, backed by an established professional network.
 </li>
 <li>
 Strong communication and coordination skills with the ability to work effectively in a multicultural environment.
 </li>
 <li>
 Strong capacity for policy research, analysis, and written reporting.
 </li>
 <li>
 Excellent problem-solving skills and strategic thinking.
 </li>
 <li>
 Integrity, dedication, and a high level of professional sensitivity and confidentiality.
 </li>
 <li>
 Ability to work both independently and as a highly effective team collaborator.
 </li>
 </ul>
 
 
</div>

Senior Government Affairs Specialist

CoorsTek, Inc.

<div>
 It's exciting to work for a company that makes the world measurably better.
 
 
 We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing.
 
 
 
 Job Title
 
 
 
 Quality Assurance Engineer I
 
 
 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.
 
 
 Key Responsibilities
 
 
 
 <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.
 </li>
 <li>
 Develop sampling plans and statistical methods for manufacturing and inspection; determine control points and charting methods.
 </li>
 <li>
 Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
 </li>
 <li>
 Develop, generate, and analyze reports and returned products to identify trends and facilitate corrective action and quality improvements.
 </li>
 <li>
 Interface with engineering and production teams to design fixtures and processes that ensure measurement system effectiveness.
 
 
 
 </li>
 </ul>
 What Makes This Role Exciting
 
 
 
 <ul>
 <li>
 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.
 </li>
 <li>
 Forefront of new product and material development &mdash; solving novel technical challenges in advanced materials used in medical applications.
 </li>
 <li>
 High visibility role with direct impact on CoorsTek&rsquo;s ability to serve medical device OEMs and grow its position as a critical supplier.
 
 
 
 </li>
 </ul>
 
 Requirements
 
 
 
 
 Education
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a related technical field; Professional Engineer (PE) and/or ASQ Certified Quality Engineer (CQE) a plus.
 
 
 
 </li>
 </ul>
 
 Experience
 
 
 
 
 <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.
 </li>
 <li>
 Background in medical device design, regulatory affairs, or quality management strongly preferred; ceramics or advanced materials experience a plus but not required.
 </li>
 <li>
 Demonstrated experience managing the technical aspects of qualifying medical devices for patient use, including recommending ISO standards, testing processes, and design controls.
 
 
 
 </li>
 </ul>
 
 Technical Skills &amp; Competencies
 
 
 
 
 <ul>
 <li>
 Working knowledge of medical device regulated quality or regulatory standards (FDA 21 CFR 820, ISO 13485).
 </li>
 <li>
 Ability to recommend and implement ISO standards, testing processes, design controls, and regulatory affairs requirements.
 </li>
 <li>
 In-depth knowledge of statistical techniques (SPC, DOE, capability studies); ability to identify, analyze, and define solutions for continuous improvement.
 </li>
 <li>
 Advanced math skills; ability to interpret and communicate technical data in mathematical or diagram form.
 </li>
 <li>
 Excellent communication skills; ability to read, analyze, and present complex technical information to diverse audiences.
 </li>
 <li>
 Effective collaborator across engineering, production, and customer-facing teams.
 </li>
 <li>
 CMM/fixture interface experience a plus, but not required.
 
 
 
 </li>
 </ul>
 
 Target Hiring Range
 
 
 
 : USD 75,000.00 - USD 91,000.00
 
 
 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.
 
 
 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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