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.

Who is Bioventus?

We are the market leader in developing clinically proven and cost-effective solutions for pain treatment & joint preservation, restorative therapies and bone graft substitutes with products recognized for their safety, innovation and effectiveness.

$500+ million in annual revenue

1100+ employees worldwide

Helping 700,000+ people every year

The Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.

The Regulatory Project Specialist provides timely and effective communication of regulatory approvals and renewals for existing products, legalizations, and Certificate to Foreign Government (CFGs), and in-process submissions. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures.Key Responsibilities:

1. Support various applications of documentation to receive product approvals for new products submissions and renewals licenses to maintain existing registrations globally.

2. Provide effective, timely, and efficient feedback to international inquiries.

3. Proved on-going support to the internal international team.

4. Provide on-going support to help resolve (potential) regulatory issues and inquiries from regulatory agencies as assigned from regulatory management.

5. Maintain accurate records and databases of regulatory submissions and approvals, including the EUDAMED system.

6. Support and coordinate legalization of Regulatory documents.

7. Coordinate administrative payment to government agencies.

8. Manage and process requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability

9. Research requirements and set priorities while maintaining project schedules.

10. Execute additional responsibilities as defined by management.

11. 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 (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.
• Experience with European Database on Medical Devices.
• 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 work in a fast paced data driven environment.
• 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.

For more information on how we use your personal data, please read the Bioventus Job Applicant Privacy Notice.