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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.

The Regulatory Operations Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, legalizations, and Certificate to Foreign Government (CFGs), including development of regulatory requirements and supporting submissions. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures

Key Responsibilities:
1. Support various applications (i.e., 510(k), PMA Supplements and Technical Documentation) to receive product clearance / approvals for new products and maintain existing registrations globally.
2. Support maintenance of Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.
3. Perform and coordinate legalization of Regulatory documents.
4. Coordinate administrative payment to government agencies.
5. Execute regulatory/legal blocks and licensing in system for various geographies worldwide.
6. Maintain dossiers and regulatory documentation organization in databases and SharePoints.
7. Communicate with Regulatory Agencies regarding requests for documentation, CFGs, declaration of conformity, and changes of products, including manufacturing, design and new product development.
8. Support Regulatory during internal audits and external audits by regulatory agencies.
9. Support Regulatory cross-functional teams for projects as assigned.
10. Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.
11. Research requirements and set priorities while maintaining project schedules.
12. Execute additional responsibilities as defined by management.

Education and Experience (Knowledge, Skills & Abilities)
• Bachelor’s Degree in Life Sciences, Engineering or other related discipline.
• 1-2 years of experience in Regulatory Affairs, preferably in the medical device industry.
• FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience.
• Ability to develop clear, concise, and timely oral and written communication and reports.
• Experience with SAP and GTS module.
• 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.

Place in the Organization: Reports to Director, Regulatory Affairs

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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.