The Senior Lifecycle Regulatory Specialist provides regulatory support of the Lifecycle (Postmarket) projects of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Lifecycle Regulatory Specialist will partner with the cross functional team members (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.
Duties and Responsibilities (Key Deliverables):
1. Communicate directly with regulatory agencies and health authorities regarding registrations, submissions and regulatory strategies.
2. In partnership with the business and regulatory colleagues (e.g., BU, Operations, and the BU, Regional and RO & RCoE RA teams) develop and execute regulatory strategies and timelines to support proposed changes to commercialized product.
3. Identify and communicate regulatory impact, regulatory requirements and submission deliverables, and execute to achieve regulatory milestones.
4. Provide input to the change teams on project and test plans, ensuring that the plans address all elements of the global regulatory strategy.
5. Maintain awareness of the global regulatory environment; assess and communicate the impact of key environmental changes LC RA initiatives and strategies environment.
6. Review and approve post-launch advertising and promotion (A&P)
7. Oversee compliance with any regulatory Conditions of Approval.
8. Support regulatory audits and inspections
9. Interpret and apply medical device regulations and standards
10. Know and apply the Quality System and any appropriate Federal and International standards.
11. Assist and support other employees, teams, and sales personnel as necessary.
Minimum of 5 years’ experience in the medical device industry specifically in Regulatory Affairs.
• Bachelor’s Degree in physical or life sciences preferred.
• Orthopaedic device industry experience preferred.
• Experience in US, EU and/or international submissions/registrations required Working knowledge of US, EU and international medical device regulations required
• Demonstrated experience leading in-depth technical and strategic discussions with Health Authorities required
• Demonstrated ability to influence and negotiate with cross-functional partners and stakeholders, both internal and external required
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific.