Global Regulatory Affairs Director — Medical Devices

Spryte Medical, LLC.; Bedford (MA); On-site; USD 215,000 - 230,000; Full time

Benefits offered by this job

Reasonable accommodations

Inclusive workplace

Job summary

Spryte Medical, LLC. is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategies for a portfolio of innovative medical devices.

You will partner with executives and cross‑functional teams to drive timely approvals and market access while building a scalable regulatory function. Responsibilities include leading complex submissions (IDE, De Novo, PMA, 510(k), EU MDR), managing regulatory agency interactions, and shaping regulatory processes for growth.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.
• Minimum 12 years of progressive Regulatory Affairs experience within medical devices.
• 3–5 years in regulatory leadership with major programs and cross-functional teams.
• Direct experience leading FDA regulatory submissions (IDE, De Novo, PMA, 510(k)).
• Experience with EU MDR and international regulatory frameworks.
• Strong regulatory writing, negotiation, and communication skills.

Responsibilities

• Lead global regulatory strategy for product development, clinical investigations, and lifecycle management.
• Represent regulatory on cross-functional teams; ensure regulatory requirements are embedded in development.
• Provide guidance to executives, Clinical Affairs, QA, Engineering, and Manufacturing.
• Manage regulatory submissions and agency interactions with FDA and global authorities.
• Build and mentor the Regulatory Affairs team and scale processes.

Skills

Regulatory strategy

Regulatory leadership

FDA submissions

Regulatory writing

Cross-functional leadership

Startup experience

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Spryte Medical, LLC. is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategies for a portfolio of innovative medical devices.

You will partner with executives and cross‑functional teams to drive timely approvals and market access while building a scalable regulatory function. Responsibilities include leading complex submissions (IDE, De Novo, PMA, 510(k), EU MDR), managing regulatory agency interactions, and shaping regulatory processes for growth.