Sr. Regulatory Affairs Specialist

Job Summary Senior Regulatory Affairs Specialist provides hands‑on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. The Sr Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits. Key Responsibilities Author and submit applications (510(k), PMA Supplements, Technical Documentation) to receive product clearance/approvals for new products and maintain existing registrations globally. Author and maintain Technical Files compliant with MDD 93/42/EEC and Technical Documentation compliant with EU MDR 2017/745. Communicate with regulatory agencies regarding submissions, changes of products, including manufacturing, design, and new product development. Represent Regulatory during internal and external audits. Participate on cross‑functional teams for projects as assigned. Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross‑functional teams. Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered. Research requirements, set priorities, and maintain project schedules. Provide guidance and oversight to team members related to regulatory compliance. Review marketing literature for compliance with applicable regulations and company policies. Execute additional responsibilities as defined by management. Qualifications Bachelor’s Degree in Life Sciences, Engineering or other related discipline. 5 years of experience in Regulatory Affairs, preferably in the medical device industry. Experience with FDA, EU, Health Canada, Brazil, Japan, and Australia registration. Ability to develop clear, concise, and timely oral and written communication and reports. Excellent communication skills, oral and written, with all levels of personnel. Detail oriented and possess considerable organizational skills. Experience with electromechanical and implantable medical devices and human tissue regulations is desirable. Ability to effectively partner with employees, management, departments, and cross‑functional teams to meet performance objectives and support the mission and vision of the company. EEO Statement Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. In the spirit of inclusivity, 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. #J-18808-Ljbffr Bioventus LLC