Sr. Principal Regulatory Affairs

Bridgeway Partners, Inc.; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

Bridgeway Partners, Inc. is searching for a Sr. Principal Regulatory Affairs leader to take strategic ownership in regulatory planning for innovative medical devices. This mid-senior level role demands a strong communicator with extensive experience in FDA submissions and global regulatory frameworks. Join a reputable company committed to improving patient lives through cutting-edge technology.

Benefits

Work from home flexibility

Access to top-tier tools and support

Supportive leadership team

Culture built on ownership and integrity

Qualifications

• 10+ years of experience in Regulatory Affairs in medical devices.
• Background with AI/ML technologies and software-based products is a plus.
• Excellent understanding of FDA and global regulations required.

Responsibilities

• Lead global regulatory strategy for Class II/III devices and software.
• Drive U.S. FDA submissions and manage agency interactions.
• Advise on regulatory pathways and influence design decisions.

Skills

Regulatory Strategy

Attention to Detail

Cross-functional Leadership

Communication

Education

Bachelor's degree in a relevant field

Job description

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Industry: Medical Device / Digital Health / Software-enabled Technology

About Us

We’re a well established, forward thinking medical device company at the forefront of innovation. Our mission is driven by cutting edge technology, from advanced software and AI-enabled platforms to cybersecurity-conscious connected devices. With a strong foundation of success and a culture built on trust, transparency, and collaboration, our leadership team is focused on long-term impact and building something meaningful.

The Role

As the Sr. Principal Regulatory Affairs leader, you’ll take ownership of strategic regulatory planning and execution for novel medical devices, including software and digitally integrated technologies. You’ll be a key player in shaping the regulatory strategy for new product introductions and sustaining programs, driving submissions globally, and collaborating closely across R&D, Quality, and Clinical teams.

This is a highly visible, hands-on role ideal for someone who thrives in a high-performing culture and is passionate about delivering game-changing technologies to patients around the world.

What You’ll Do

• Lead global regulatory strategy for complex Class II/III devices, software, connected platforms, and traditional hardware
• Drive U.S. FDA submissions (510(k), IDE, PMA) and manage responses and agency interactions
• Coordinate EU MDR technical documentation and other international filings
• Advise cross-functional teams on regulatory pathways, documentation, and compliance requirements
• Provide senior level input on risk assessments and influence design decisions early in development
• Represent Regulatory on project teams and mentor others across the function
• Collaborate with cybersecurity, digital health, and software engineering stakeholders on future-focused regulatory frameworks
• Maintain awareness of evolving global regulatory trends and translate them into strategic guidance
• Contribute to regulatory policy development and internal best practices

What We’re Looking For

• 10+ years of experience in Regulatory Affairs within the medical device industry
• Proven track record with U.S. submissions (510(k), PMA, IDE); international experience a plus
• Background with software-based products, AI/ML technologies, or cybersecurity a strong plus
• Excellent understanding of FDA and global regulations, including EU MDR
• Experience guiding cross-functional teams and influencing executive-level decisions
• Highly organized, self-motivated, and comfortable managing multiple complex projects
• Strong communicator with an ability to convey regulatory strategy clearly and persuasively

Why Join Us?

• A stable, profitable company with strong growth and investment in innovation
• A mission driven environment where your work directly improves lives
• Work from home flexibility with top tier tools and support
• A leadership team that truly listens and supports your development
• Culture built on ownership, integrity, and excellence

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Science, and Strategy/Planning

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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