The Solheim Group is actively recruiting for permanent Regulatory Specialists for a Medical Device Orthopedics company.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.
Education: Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
- Minimum of 5 years’ experience in the medical device industry specifically in Regulatory Affairs.
- Bachelor’s Degree in physical or life sciences preferred.
- Orthopedic 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
- Regulatory Affairs Certification (RAC) preferred
Functional/Technical Knowledge, Skills and Abilities Required: • Proficiency with windows-based office productivity tools (Microsoft Office)
Please send inquires or resume to firstname.lastname@example.org