Life Sciences Job at Bioventus USA
Looking for a rewarding life sciences job that offers hands-on regulatory experience in the USA? This entry-level Regulatory Operations Specialist role at Bioventus is an excellent job opportunity for life science graduates seeking to build a strong foundation in global regulatory affairs within a fast-growing medical device company.
About Bioventus
Bioventus is committed to helping patients resume and enjoy active lives. The company believes its success depends on developing its people and fostering a collaborative, inclusive workplace where diverse perspectives are valued. Bioventus invests in employee growth, encourages continuous learning, and promotes teamwork to achieve shared goals.
Job Details:
- Job Title: Regulatory Operations Specialist (Entry-Level Regulatory Associate)
- Company: Bioventus
- Location: Durham, North Carolina, United States
- Employment Type: Full-time
- Job Requisition ID: R-2025-12-001468
Regulatory Operations Specialist Position Overview
Bioventus is seeking a motivated, growth-oriented Regulatory Operations Specialist to join its fast-paced Regulatory Affairs team. This entry-level role is ideal for individuals at the beginning of their regulatory careers who are looking to gain hands-on experience in medical device regulatory operations.
The role provides regulatory affairs support for new product approvals, renewals of existing product registrations, document legalizations, and Certificates to Foreign Government (CFGs). Responsibilities include supporting regulatory submissions and ensuring compliance with applicable regulations, standards, and internal policies.
Key Responsibilities
- Support regulatory applications, including 510(k), PMA Supplements, and Technical Documentation, to obtain product approvals and maintain global registrations
- Maintain Technical Files compliant with MDD 93/42/EEC and Technical Documentation compliant with EU MDR 2017/745
- Perform and coordinate legalization of regulatory documents
- Coordinate administrative payments to government agencies
- Execute regulatory and legal blocks and licensing activities in internal systems for global markets
- Maintain organized regulatory dossiers and documentation within databases and SharePoint systems
- Communicate with regulatory agencies regarding documentation requests, CFGs, declarations of conformity, and product changes related to manufacturing, design, and new product development
- Support internal audits and external regulatory agency audits
- Support cross-functional regulatory project teams as assigned
- Perform regulatory assessments for design, manufacturing, and labeling changes to ensure ongoing compliance
- Research regulatory requirements, set priorities, and maintain project schedules
- Perform additional responsibilities as defined by management
Education & Experience (Knowledge, Skills & Abilities)
- Bachelor’s degree in Life Sciences, or a related discipline
- 1–2 years of Regulatory Affairs experience, preferably within the medical device industry
- Experience with FDA, EU, Health Canada, Brazil, Japan, and Australia registrations
- Experience using SAP, including the GTS module
- Ability to produce clear, concise, and timely written and verbal communications
- Strong attention to detail and organizational skills
- Excellent communication skills with all levels of personnel
- Ability to partner effectively with employees, management, and cross-functional teams to support company objectives
Highlights of Life Sciences Job
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Entry-level life sciences job in regulatory affairs
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Full-time job in USA (Durham, NC)
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Global regulatory exposure (FDA, EU MDR, international markets)
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Strong career development at Bioventus careers
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Ideal job opportunity for life science graduates
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Hands-on experience with medical device submissions
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Collaborative, growth-focused work culture
