Regulatory Affairs Manager

Regulatory Affairs Manager

Bioventus is a global leader in developing clinically proven, cost‑effective solutions for pain treatment, joint preservation, restorative therapies, and bone graft substitutes. The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and maintain compliance with national and international regulatory requirements (e.g., U.S. FDA, Health Canada, EU notified bodies).

Key Responsibilities

1. Prepare and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.
2. Develop and maintain outstanding relationships with all regulatory and compliance agencies and provide appropriate interface in pre‑ and post‑marketing forums, offering guidance, interpretation, and opinions on complex regulatory matters.
3. Prepare, collect, review, and assemble technical documentation required for regulatory and clinically‑related submissions such as U.S. 510(k), PMAs, IDEs, NDAs, INDs, or international dossiers for new and modified products.
4. Liaise with project teams to develop regulatory strategies, testing requirements, and other documentation to ensure regulatory data requirements are met.
5. Serve as the point person for regulatory agency interactions, including preparation of briefing packages, presentations, and strategies for meetings, and response to agency letters pertaining to assigned products.
6. Monitor proposed and current global regulations and standards; assess impact of changes on assigned biologics product lines.
7. Maintain awareness of global regulatory legislation and assess its impact on development and manufacturing initiatives.
8. Evaluate design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.
9. Identify and facilitate the remedy of inefficiencies in quality systems and processes.
10. Contribute to the regulatory and/or quality perspective on due diligence activities to identify issues related to the target product’s development and/or manufacture.
11. Hold oneself and others accountable to conduct business in compliance with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
12. Perform all other duties or projects as assigned.

Education and Experience

• Bachelor’s degree required (preferred in Engineering or life sciences, other degrees may be considered).
• Extensive knowledge of FDA and applicable international regulations (e.g., US QSRs, GMPs, ISO 13485).
• Minimum of 5–7 years of regulatory and quality regulatory experience and submission experience.
• ClassII medical device experience required; ClassIII medical device and/or PMA/BLA/NDA submissions experience desired.
• Experience interacting with the U.S. FDA is required.
• Excellent written, verbal communication and presentation skills.
• Strong interpersonal skills, ability to remain calm, professional, diplomatic, and positive.
• Detail‑oriented with ability to handle multiple projects/tasks.

Equal Opportunity Employer

Bioventus is committed to fostering an inclusive and diverse community of employees. 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.