Regulatory Affairs Manager

Key Responsibilities

• Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.
• Develop and maintain outstanding relationships with all regulatory and compliance agencies.
• Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums.
• Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.
• Prepares, collects, reviews, and assembles technical documentation required for writing regulatory and clinically-related submissions such as US 510K, PMAs, IDEs, NDAs, INDs, or international dossiers for new and modified products.
• Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met.
• Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products.
• Maintain awareness of global regulatory legislation and assess its impact on development and manufacturing initiatives.
• Evaluates design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

Education And Experience

• Bachelor’s degree required (study area in Engineering or life sciences preferred, but other degrees may be considered)
• Extensive knowledge of FDA and applicable international regulations required.
• Working knowledge of US Quality Systems Regulations (QSRs) and/or Good Manufacturing Practices (GMPs), along with ISO 13485.
• Minimum of 5 – 7 years of Regulatory and Quality regulations experience and submission experience required.
• Class II medical device experience required, Class III medical device and/or PMA / BLA/NDA submissions experience desired.
• Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.
• Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
• Being detail-oriented while having the ability to handle multiple projects/tasks.
• Experience interacting with US FDA is required.