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Job description
Position
Senior Regulatory Affairs Specialist – Durham, NC – Bioventus LLC.
Responsibilities
Author and submit regulatory applications (510(k), PMA supplements, and technical documentation) to obtain product clearance and approvals for new products and maintain existing registrations globally.
Author and maintain Technical Files compliant with MDD 93/42/EEC and EU MDR 2017/745.
Communicate with regulatory agencies regarding product submissions, changes (manufacturing, design, new development), and to represent regulatory affairs during internal and external audits.
Review protocols, reports, and marketing literature for scientific validity and regulatory compliance, providing scientific judgment to guide cross‑functional teams.
Perform regulatory assessments for design, manufacturing, and labeling changes to ensure compliance with applicable regulations and standards where the product is registered.
Research requirements, set priorities, and maintain project schedules; provide guidance and oversight to team members on regulatory compliance matters.
Qualifications
Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, or a related field, plus a minimum of 3 years of experience in a regulatory affairs or related role within the medical and/or diagnostic device industry.
3+ years of experience with regulatory assessment of engineering/design change execution; guiding cross‑functional teams; and preparing submission documents.
Regulatory registrations in at least three of the following agencies or regions: FDA, EMEA, Canada, LATAM, Japan, Australia.
Experience with product changes and submissions compliant with Medical Device Regulation (MDR) and EU Medical Device Directive (MDD).
Project management experience and proficiency in preparing and reviewing documentation regarding product changes.
Work Arrangement
Hybrid model: 3 days in office and 2 days remote within commuting distance.
National travel required approximately 25% of the time.
EEO Statement
Bioventus is committed to fostering an inclusive and diverse community. Qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion, or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.
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Worksite address
durham, NC, 27703, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.