Senior Regulatory Affairs Lead – Med Devices & Biologics

LifeNet Health; Virginia Beach (VA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

LifeNet Health’s Regulatory Affairs team seeks a Senior Regulatory Affairs Specialist in Virginia Beach to drive global regulatory strategy and timely submissions for medical devices and biologics.

You will collaborate with cross-functional teams to ensure compliance, plan US and international dossiers, and navigate post-approval changes while supporting marketing claims. This role offers impactful work in regenerative medicine.

Qualifikationen

• 5 years of regulatory experience in medical device or similar regulated industry.
• 2 years of experience with high-risk (e.g., Class 3/PMA) regulated products in the US, EU, and other geographies.

Aufgaben

• Develop creative regulatory strategies for new product development teams.
• Plan and submit product dossiers for US and international regulatory approval.
• Evaluate post-approval design and manufacturing changes and develop submission plans.
• Support the development and negotiation of appropriate marketing claims with commercial teams.
• Lead continuous improvement projects using LEAN principles.

Kenntnisse

Regulatory strategy

Regulatory approvals

Cross-functional collaboration

Ausbildung

Bachelor's Degree

Tools

Regulatory submissions software

Jobbeschreibung

LifeNet Health’s Regulatory Affairs team seeks a Senior Regulatory Affairs Specialist in Virginia Beach to drive global regulatory strategy and timely submissions for medical devices and biologics.

You will collaborate with cross-functional teams to ensure compliance, plan US and international dossiers, and navigate post-approval changes while supporting marketing claims. This role offers impactful work in regenerative medicine.