Global VP of Regulatory Strategy & Submissions

Bridgeway Partners, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Bridgeway Partners, Inc. seeks a Vice President, Regulatory Affairs to provide strategic and operational leadership for a global medical device and diagnostics business.

This executive will develop and execute regulatory strategies to support product innovation, commercialization, lifecycle management, and growth. In partnership with R&D, Quality, Clinical/Medical Affairs, Marketing, Legal and Operations, the VP will ensure regulatory considerations are embedded in development and business

Qualifications

• Bachelor's degree in biology, chemistry, engineering, life sciences or related field.
• Advanced degree (MS, MBA, PhD) preferred.
• Regulatory Affairs Certification (RAC) is a plus.
• 15+ years of progressively responsible Regulatory Affairs experience in medical devices/diagnostics.
• Experience obtaining regulatory clearances in US and international markets.
• Strong business acumen balancing regulatory, patient needs, risk, innovation, and commercial objectives.
• Executive presence and credibility when interacting with senior leadership, regulatory agencies, and external stakeholders.

Responsibilities

• Develop and lead global regulatory strategies to support objectives and lifecycle management.
• Serve as strategic regulatory partner to senior leadership, helping evaluate opportunities and set priorities.
• Provide executive oversight of global premarket regulatory activities and submissions.
• Represent the organization in interactions with FDA and other regulatory authorities.
• Establish regulatory strategies for medical devices and diagnostic products across US and international markets.
• Partner with R&D, Quality, Clinical/Medical Affairs, Marketing, Operations to embed regulatory requirements throughout development and commercialization.
• Provide leadership for regulatory submissions, including 510(k)s, IDEs, EU Technical Documentation/Files, and other registrations.
• Mentor and develop Regulatory Affairs professionals and build succession plans.
• Build productive relationships with regulatory agencies, industry organizations, and external stakeholders.

Skills

Strategic leadership

Regulatory leadership

Executive presence

Cross-functional collaboration

Regulatory communication

Education

Bachelor's degree in biology, chemistry, engineering, life sciences

Advanced degree preferred (MS, MBA, PhD)

RAC certification (preferred)

Job description

Bridgeway Partners, Inc. seeks a Vice President, Regulatory Affairs to provide strategic and operational leadership for a global medical device and diagnostics business.

This executive will develop and execute regulatory strategies to support product innovation, commercialization, lifecycle management, and growth. In partnership with R&D, Quality, Clinical/Medical Affairs, Marketing, Legal and Operations, the VP will ensure regulatory considerations are embedded in development and business