Senior Regulatory Affairs Specialist

Bioventus • Durham, NC

1d • Hybrid

About The Position

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. Bioventus LLC., seeks Senior Regulatory Affairs Specialist (Durham, NC).

Requirements

• Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry.
• 3 years of experience with: Regulatory assessment of engineering/design change execution.
• Working with or providing guidance to cross-functional or offshore team in preparation of documents for regulatory agency submissions.
• Regulatory registrations in at least 3 or more of the following agencies or regions (FDA, EMEA, Canada, LATAM, Japan, Australia).
• Project management.
• Preparing and reviewing documentation regarding submissions and product changes of medical devices.
• Experience working with medical device registrations compliant with Medical Device Regulation and EU Medical Device Directive.

Responsibilities

• Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.
• Author and maintain Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.
• Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development.
• Serve as Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies.
• 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 and set priorities while maintaining project schedules.
• Provide guidance and oversight to team members related to regulatory compliance.
• Review marketing literature for compliance with applicable regulations and company policies and procedures.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior