Regulatory Affairs Program Manager

Stark Pharma Solutions Inc; Raynham (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced Regulatory Affairs Program Manager to lead a large-scale Medical Device Divestiture initiative.

The role will oversee transfer of global regulatory registrations, submissions, and documentation to a newly established medical device entity, ensuring regulatory compliance and seamless execution. The ideal candidate has 10+ years in medical device regulatory affairs, hands-on divestiture experience, and strong program management skills to

Qualifications

• 10+ years regulatory affairs experience in the Medical Device industry.
• Hands-on with Divestiture/Business Separation projects.
• Strong Regulatory Program Management capabilities.
• Expertise with FDA 510(k), PMA submissions and global registrations.
• Knowledge of registration ownership transfers, submission pathways, and health authority interactions.
• Excellent communication, leadership, and stakeholder management skills.

Responsibilities

• Lead regulatory activities supporting a global divestiture program.
• Complete and execute the Regulatory Registration Transfer Strategy.
• Manage ownership transfers, amendments, renewals, notifications, and new submissions.
• Coordinate with cross-functional Regulatory, Quality, and Project teams.
• Identify project risks, develop mitigation plans, and ensure GMP compliance.
• Maintain project documentation, timelines, and stakeholder communication.

Skills

Regulatory Affairs

Divestiture/Business Separation

Regulatory Program Management

FDA Submissions (510(k), PMA)

Global Regulatory Registrations

Leadership & Stakeholder Mgmt

Job description

Regulatory Affairs Program Manager (Medical Device Divestiture)

Location: Raynham, MA / West Chester, PA / Palm Beach Gardens, FL (Hybrid 3-4 days onsite)

Duration: 12+ Months (Extension Possible)

Overview

We are seeking an experienced Regulatory Affairs Program Manager to lead a large-scale Medical Device Divestiture initiative. This role will manage the transfer of global regulatory registrations, submissions, and documentation from a large healthcare organization to a newly established medical device company while ensuring regulatory compliance and seamless execution.

Key Responsibilities

• Lead regulatory activities supporting a global divestiture program.
• Complete and execute the Regulatory Registration Transfer Strategy.
• Manage ownership transfers, amendments, renewals, notifications, and new submissions.
• Coordinate with cross-functional Regulatory, Quality, and Project teams.
• Identify project risks, develop mitigation plans, and ensure GMP compliance.
• Maintain project documentation, timelines, and stakeholder communication.

Required Skills

• 10+ years of Regulatory Affairs experience in the Medical Device industry.
• Hands‑on experience with Divestiture/Business Separation projects.
• Strong Regulatory Program Management experience.
• Expertise with FDA 510(k), PMA, global registrations, labeling changes, design changes, and regulatory submissions.
• Knowledge of registration ownership transfers, submission pathways, and health authority interactions.
• Excellent communication, leadership, and stakeholder management skills.