Sr Regulatory Affairs Specialist - Electrical devices

Bioventus - Durham, NC

Full-time - Mid Level

Durham, NC

Miscellaneous Manufacturing

About the position

The Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. Responsibilities include compliance with applicable domestic and international regulations, standards and established corporate policies and procedures.

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.
• Participate on cross-functional teams for projects as assigned.
• 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.
• Execute additional responsibilities as defined by management.

Requirements

• Bachelor's Degree in Life Sciences, Engineering or other related discipline.
• 5 years of experience in Regulatory Affairs, preferably in the medical device industry.
• FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience. Additional geographical experience preferred.
• 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.
• 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.