regulatory affairs strategy specialist

Johnson & Johnson

<div>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that&rsquo;s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world&rsquo;s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.
Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and global health authorities. Through your engagement in this role, you will help shape the surgical field.
You will be responsible for:<ul><li>
Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies).</li><li>
Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.</li><li>
Maintain device registrations and licenses throughout product lifecycle. Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions. Assist in the development of multi-country regulatory strategy.</li><li>
Monitor changes in regulations. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.</li><li>
Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).</li></ul>
Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.<ul><li>
Able to manage multiple overlapping priorities across projects.</li></ul>
Qualifications / Requirements:<ul><li>
Minimum of a Bachelor&rsquo;s Degree required. Science or Engineering discipline highly desired.</li><li>
At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).</li><li>
Ability to comprehend principles of engineering, physiology and medical device use.</li><li>
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.</li><li>
Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.</li><li>
Strong verbal communication and regulatory/medical writing skills.</li><li>
Ability to effectively manage multiple projects and priorities.</li><li>
Exhibit leadership traits such as a positive, forward looking appraoch to problem-solving, and accountable, action-oriented, appraoch to deliver results. Results oriented and ability to meet project schedules.</li><li>
Enjoy teamwork and thrive as a member of cross-functional teams.</li><li>
Be adaptable and thrive in a dynamic work environment where variety is the routine.</li><li>
Experience with US Class II device submissions .</li><li>
Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.</li><li>
Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.</li><li>
Travel up to 10%.</li></ul>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is :
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)). 
 
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 
 
Vacation &ndash;120 hours per calendar year 
 
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year 
 
Holiday pay, including Floating Holidays &ndash;13 days per calendar year 
 
Work, Personal and Family Time - up to 40 hours per calendar year 
 
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child 
 
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year 
 
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days 
 
Volunteer Leave &ndash; 32 hours per calendar year 
 
Military Spouse Time-Off &ndash; 80 hours per calendar year 
 
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid</div>

Senior Regulatory Affairs Specialist - MedTech Surgery

Stellar Hunters

<div><h4 class="jobSectionHeader">Job Summary</h4>
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.<h4 class="jobSectionHeader">
Key Responsibilities</h4><h5 class="jobSectionHeader">
Regulatory Submissions &amp; Approvals</h5><ul><li>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</li><li>
Track and manage product registration timelines, renewals, and approvals.</li></ul><h5 class="jobSectionHeader">
Compliance &amp; Documentation</h5><ul><li>
Ensure all products and processes comply with local and international regulatory requirements.</li><li>
Maintain up-to-date regulatory documentation, technical files, and records.</li></ul><h5 class="jobSectionHeader">
Regulatory Intelligence</h5><ul><li>
Monitor changes in regulations and guidelines and assess their impact on the business.</li><li>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</li></ul><h5 class="jobSectionHeader">
Cross-functional Collaboration</h5><ul><li>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</li><li>
Support new product development by providing regulatory guidance and requirements.</li></ul><h5 class="jobSectionHeader">
Audit &amp; Inspection Support</h5><ul><li>
Support internal and external audits, inspections, and regulatory inquiries.</li><li>
Ensure readiness and proper documentation for compliance reviews.</li></ul><h5 class="jobSectionHeader">
Labeling &amp; Claims Review</h5><ul><li>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</li><li>
Ensure all product claims are supported and aligned with regulatory standards.</li></ul><h5 class="jobSectionHeader">
Continuous Improvement</h5><ul><li>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</li></ul><h4 class="jobSectionHeader">
Required Qualifications - Skills &amp; Experience</h4><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</li><li>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</li><li>
Strong knowledge of regulatory frameworks and submission processes.</li><li>
Experience with product registration and regulatory documentation.</li><li>
Excellent attention to detail and organizational skills.</li><li>
Strong communication and stakeholder management skills.</li></ul><h4 class="jobSectionHeader">
Preferred Qualifications</h4><ul><li>
Experience with Saudi regulatory bodies such as SFDA.</li><li>
Familiarity with GCC or international regulatory requirements.</li><li>
Experience with electronic submission systems and regulatory databases.</li><li>
Certification or training in regulatory affairs is a plus.</li></ul><h4 class="jobSectionHeader">
Work Environment &amp; Compensation</h4><ul><li>
Full-time position with an onsite model.</li><li>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</li><li>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</li><li>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</li></ul></div>

Regulatory Affairs Specialist

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 &nbsp;
 
 
 
 Job Summary:
 
 
 
 We are seeking a passionate and talented
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 <ul>
 <li>
 Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmaceutical Sciences
 </li>
 <li>
 +2 years of experience in Regulatory Affairs in international Markets.
 </li>
 <li>
 Fluent in English (written &amp; verbal) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
 
 
</div>

Kraft Heinz

<div>
 The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
 </li>
 <li>
 Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
 </li>
 <li>
 Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
 </li>
 <li>
 Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
 </li>
 <li>
 Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
 </li>
 <li>
 Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
 </li>
 <li>
 Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
 </li>
 <li>
 Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
 </li>
 <li>
 Proactively identify and communicate SRA risk in any project or work stream
 </li>
 <li>
 Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
 </li>
 <li>
 Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
 </li>
 <li>
 Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
 </li>
 <li>
 Provide technical and legal labelling Information and support artwork approval process
 </li>
 <li>
 Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
 </li>
 <li>
 Scientific and regulatory affairs representation in all projects driven forums
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
 </li>
 <li>
 5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
 </li>
 <li>
 Experience working with Microsoft programs and system tools related to recipes and artworks
 </li>
 <li>
 Experience in translation is preferred
 </li>
 <li>
 Fluent in Arabic &amp; English, French is a plus
 </li>
 </ul>
</div>

Scientific & Regulatory Affairs Specialist – Africa & Trading

<div><div>The Kraft Heinz Company is looking for a Scientific and Regulatory Affairs Specialist who will support scientific and regulatory activities to help ensure products comply with applicable regulations and internal standards. This role will collaborate cross-functionally to review product formulations, ingredients, labeling, and claims; prepare and maintain regulatory documentation; monitor regulatory changes; and provide guidance to internal stakeholders throughout product development and commercialization. The ideal candidate has a strong foundation in food science and regulatory requirements, excellent attention to detail, and the ability to communicate clearly with partners across R&amp;D, Quality, Legal, and Commercial teams. 
</div><div></div> 
<div>Key Responsibilities:
</div><ul><li>Responsible for providing timely compliance input to all projects and ensure it meets and aligns with food compliance related laws, legislation, and regulations across Africa &amp; Trade markets
</li><li>Responsible to give compliance guidance in work streams, and to follow up, verify and validate execution of such actions by stakeholders
</li><li>Accountable for validating that ingredients, formulas, labelling, and claims are in full compliance with laws and regulations in markets been sold
</li><li>Communicate anticipated issues and provide regulatory support and compliance guidance for projects handled to the relevant stakeholders and forums
</li><li>Support a proactive strategic approach in regulatory function to identify, monitor, analyze early signals of upcoming regulations that might have impact in A&amp;T market, categorize them as per their likelihood and potential impact for the business.
</li><li>Build and maintain relationships with the relevant industrial groups and authorities to maintain awareness of new food legislations.
</li><li>Track- monitor and report on the completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
</li><li>Drive cross-functional cooperation to effectively respond to regulatory related questions, challenges and issues raised for local, import and export products.
</li><li>Proactively identify and communicate SRA risk in any project or work stream
</li><li>Accountable to ensure risk assessment and mitigation plans are communicated to stakeholders
</li><li>Lead the registration process, collecting relevant documents, and keeping track of license expiration for the relevant SSA markets
</li><li>Drive a culture of scientific and regulatory affairs adherence to internal and external compliance processes and practices, driving continuous improvements opportunities
</li><li>Provide technical and legal labelling Information and support artwork approval process
</li><li>Ensure consistency and synergy in label &amp; declarations on packaging across A&amp;T markets (especially shared artworks)
</li>Scientific and regulatory affairs representation in all projects driven forums 
<li>
</li></ul><div></div> 
<div>Qualifications:
</div><ul><li>Bachelor&rsquo;s degree in pharmacy, Biotechnology, or Food Science
</li><li>5 years of experience in regulatory compliance/affairs preferably within a food, beverage, or consumer sector
</li><li>Experience working with Microsoft programs and system tools related to recipes and artworks
</li><li>Experience in translation is preferred
</li><li>Fluent in Arabic &amp; English, French is a plus</li></ul></div>

Masimo

<div>Duties &amp; Responsibilities:
<ul><li>Process and maintain international filings/registrations in the assigned countries within the META Region.
</li><li>Generate and maintain product and process compliance checklists for the assigned countries.
</li><li>Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries.
</li><li>Provide counsel, training, and interpretation of applicable META Region regulatory requirements to company personnel.
</li><li>Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
</li><li>Support operations, marketing, and sales with global market approvals for product shipment.
</li><li>Prepare and maintain other regulatory documentation, as needed in the assigned countries.
</li><li>Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
</li><li>Generate/update quality system procedures owned by Regulatory Affairs, as required.
</li><li>Participate in relevant projects as regulatory subject matter expert.
</li><li>Perform other duties or special projects, as assigned.
</li><li>Collaborate with QA to drive Quality compliance in the region 
</li></ul>Minimum Qualifications:
<ul><li>Minimum 3 years of experience in international medical device Regulatory Affairs.
</li><li>Experience with the current Middle East regulations
</li><li>Excellent verbal and written communication skills in English.
</li><li>Experience working remotely with in-country representatives and with USA-based headquarters.
</li><li>Excellent prioritizing, organizational and interpersonal skills.
</li><li>Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
</li><li>Ability to work in a fast-paced environment, with multiple tasks/projects.
</li><li>A detailed-oriented individual with a &ldquo;can do&rdquo; attitude and ability to work in a team environment as well as individually with minimal supervision. 
</li></ul>Preferred Qualifications: 
<ul><li>3-7 years of related work experience.
</li><li>Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
</li><li>Good knowledge of the META Region regulations on electro-medical devices.
</li><li>Experience interacting with regulatory bodies.
</li><li>Proficient in document management systems, such as Oracle Agile PLM.
</li><li>Prior experience working within countries in Middle East &amp; Africa.
</li><li>Prior experience working in international organizations. 
</li></ul>Education: 
BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering. 
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
Please send your full application.
To learn more about us, please visit: www.masimo.com</div>

Regulatory Affairs Specialist I

Confidential Government

<div>
 
 
 Job Summary
 
 
 
 
 
 
 Supports the effective governance and administrative operations of the Board by coordinating meetings, preparing documentation, ensuring compliance, and facilitating communication between the Board and executive management.
 
 
 
 
 
 
 Main Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Coordinate and organize Board and committee meetings
 </li>
 <li>
 Prepare agendas, board packs, and official documentation
 </li>
 <li>
 Record and maintain accurate minutes and resolutions
 </li>
 <li>
 Track implementation of Board decisions and action items
 </li>
 <li>
 Ensure compliance with governance frameworks and regulatory requirements
 </li>
 <li>
 Maintain confidential records and official Board documentation
 </li>
 <li>
 Liaise between Board members and executive leadership
 </li>
 <li>
 Support annual planning, reporting, and governance reviews
 </li>
 </ul>
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Business Administration, Law, or related field
 </li>
 <li>
 2 &ndash; 4 years of experience in board affairs, governance, or executive office roles
 </li>
 <li>
 Strong knowledge of corporate governance practices
 </li>
 <li>
 Excellent documentation, communication, and organizational skills
 </li>
 <li>
 High level of professionalism and confidentiality
 </li>
 </ul>
 
 
</div>

Board Affairs Specialist

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