Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist Durham, NC Job Details Full-time 1 day ago Qualifications FDA submissions Internal controls Report writing Technical documentation Engineering Compliance audits & assessments Project timeline management Research 8 years Bachelor's degree in engineering Bachelor's degree Team management Organizational skills Technical writing Regulatory submissions Senior level Cross-functional collaboration Communication skills Project scheduling Regulatory compliance management Cross-functional communication Internal audits Full Job Description Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives. Main Purpose of the Role The Principal 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 Principal Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures.

Key Responsibilities:

1. Author and submit applications 510(k), PMA, IDE, PMA Supplements, and Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally, per applicable regulations. 2. Perform specialized level work assignments and/or analysis evaluation, preparation, and submission of documentation for the global regulatory registration. 3. Develop global strategies for regulatory approval of new and modified products. 4. Guide teams to provide content for submission and participate in design reviews. 5. Subject Matter Expert for Ad Promo of global product portfolio. 6. Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development. 7. Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies. 8. Maintain ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements globally are current and up to date. 9. Participate on cross-functional teams for projects as assigned. 10. Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams. 11. Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered. 12. Research requirements and set priorities while maintaining project schedules. 13. Provide guidance and oversight to team members related to regulatory compliance. 14. Reviewing marketing literature for compliance with applicable regulations and company policies and procedures. 15. Hold 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. 16. Execute additional responsibilities as defined by management. Education and Experience (Knowledge, Skills & Abilities) Bachelor's Degree in Life Sciences, Engineering or other related discipline. Minimum 8 years of experience in Regulatory Affairs Experience in the medical device industry preferred; experience with electromechanical and implantable medical devices and human tissue regulations is desirable. FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience. Ability to develop clear, concise, and timely oral and written communication and reports. Excellent communication skills, oral and written, with all levels of personnel. Must be detail oriented and possess considerable organizational skills. Ability to effectively partner with employees, management, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company. Are you the top talent we are looking for? Apply now! Hit the "Apply" button to send us your resume and cover letter. Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. 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.