Bioventus
Sr Regulatory Affairs Specialist International
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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.
Key Responsibilities:
- Registration support; maintenance of current existing registrations, new registrations (Eastern Europe, MEA, APAC – non-EU countries).
- Liaise with US Regulatory and Quality teams to facilitate projects and ensure communication with international leader and team.
- Provide on-going support to help resolve (potential) regulatory issues and inquiries from regulatory agencies/distributors as defined by regulatory and business needs.
- Process Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability, legalization of documentation as required to register and renew products in region.
- Timely and effective communication of regulatory approvals and renewals for existing products.
- Ensure appropriate product certifications are in place prior to commercial distribution in region.
- Execute additional responsibilities as defined by Regulatory management.
- 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.
- Proactively identifies opportunities and potential challenges at the intersection of business and regulatory requirements and takes appropriate action.
- Actively participates in the ILT and maintains strong alignment with international business.
- Aligns priorities and provide regular, structured updates on progress across key projects.
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Education And Experience (Knowledge, Skills & Abilities)
- Bachelor’s Degree in Life Sciences, Engineering or other related disciplines.
- 5 years of experience in Regulatory Affairs, preferably in the medical device industry.
- International registration experience (Eastern Europe, MEA, APAC – non EU countries).
- Ability to develop clear, concise, and timely oral and written communication and reports and collaboration across time zones.
- Excellent communication skills, oral and written, with all levels of personnel.
- Must be 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, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company.
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Place in the Organization:
Reports to: Manager 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.
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