Remote Regulatory Affairs Manager - Medical Devices

Jobgether; United States; À distance; USD 120 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health and dental insurance options

401(k) retirement plan with employer

Employee Stock Ownership Plan (ESOP)

Generous paid time off (PTO)

Paid holidays and sick leave

Professional development funding

Résumé du poste

Jobgether, a partner company, is seeking a Regulatory Affairs Manager – Medical Devices based in the United States. You will lead global regulatory strategies and ensure compliance across the product lifecycle.

Collaborate with Engineering, Quality, Product Development, and leadership to embed regulatory requirements in design and development, manage submissions, and support market access across international markets.

Qualifications

• Bachelor's in Engineering or life sciences.
• 7–10 years in medical device regulatory affairs.
• 3+ years of leadership or project management.
• Experience with FDA submissions and international registrations.
• Knowledge of FDA MDR UK Canada MDSAP.
• ISO 13485 QMS experience.
• Strong leadership and communication skills.
• RAC or CQE certifications preferred.

Responsabilités

• Develop global regulatory strategies for device lifecycle.
• Lead regulatory submissions and registrations.
• Advise leadership on regulatory risks.
• Mentor Regulatory Affairs team.
• Ensure QMS alignment with regulatory standards.
• Collaborate with engineering for compliant designs.
• Maintain relationships with authorities and notified bodies.
• Monitor regulatory changes and guidance.

Connaissances

Regulatory leadership

FDA submissions

Project management

Regulatory affairs

MDR knowledge

Quality Systems

Formation

Bachelor's degree in Engineering

Master's degree preferred

Description du poste

Jobgether, a partner company, is seeking a Regulatory Affairs Manager – Medical Devices based in the United States. You will lead global regulatory strategies and ensure compliance across the product lifecycle.

Collaborate with Engineering, Quality, Product Development, and leadership to embed regulatory requirements in design and development, manage submissions, and support market access across international markets.