Principal Regulatory Affairs Leader

BioTalent; Nevada; Hybrid; USD 180,000 - 240,000; Full time

Job summary

BioTalent is seeking a Principal Regulatory Affairs Leader for a medical device client in the United States. The role blends regulatory strategy, submissions, and compliance across a diverse product portfolio, with hybrid work balancing remote and on-site monthly expectations.

You will partner with R&D, Quality, Clinical, and executive teams to shape strategy, guide product approvals, mentor stakeholders, and ensure readiness for audits and inspections.

Qualifications

• 10+ years in medical device regulatory affairs.
• Experience with Class II/III devices and submissions.
• Strong FDA regulatory knowledge and global activities a plus.

Responsibilities

• Develop and execute regulatory strategies for development and lifecycle.
• Lead regulatory submissions and engage with authorities.
• Advise on US and international regulatory requirements.
• Review technical docs to identify gaps and mitigations.
• Collaborate with R&D, QA, clinical and leadership teams.
• Mentor stakeholders and support audit readiness.
• Monitor regulatory changes and advise on business impact.
• Support post-market activities and risk management.

Skills

Regulatory strategy

Cross-functional leadership

FDA regulations

Product lifecycle

Team mentorship

Communication

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Medical Device Industry | Confidential Opportunity | Hybrid (monthly onsite)

Are you a regulatory affairs professional who enjoys shaping strategy, influencing cross-functional teams, and bringing innovative medical technologies to market?

We're working with a premier medical device manufacturer to find a Principal Regulatory Affairs Leader to play a key role in regulatory strategy, product approvals, and compliance across a diverse product portfolio. This position offers the opportunity to work closely with R&D, Quality, Clinical, and executive leadership teams while helping guide products through complex regulatory pathways.

Key Responsibilities

• Develop and execute regulatory strategies to support product development, market access, and lifecycle management.
• Lead regulatory submissions and interactions with regulatory authorities.
• Provide strategic guidance on U.S. and international regulatory requirements.
• Review technical documentation and identify compliance gaps.
• Partner with cross-functional teams throughout the product development process.
• Support risk management, labeling, clinical, and post-market activities from a regulatory perspective.
• Assist in audit and inspection readiness activities.
• Monitor evolving regulatory requirements and provide recommendations on business impact.
• Serve as a regulatory subject matter expert and mentor internal stakeholders.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related scientific discipline.
• 10+ years of experience within the medical device industry.
• Significant Regulatory Affairs experience supporting Class II and/or Class III medical devices.
• Demonstrated success developing regulatory strategies and supporting product approvals.
• Strong understanding of FDA regulations, quality systems, and risk management principles.
• Experience supporting global regulatory activities is a plus.
• Excellent communication, collaboration, and project leadership skills.
• Ability to influence stakeholders across technical and business functions.

Why This Opportunity?

• High-visibility role with strategic impact across the organization.
• Opportunity to influence the direction of innovative medical device programs.
• Collaborative environment with strong cross-functional engagement.
• Career growth within a well-established and expanding medical technology company.
• Ability to make a meaningful impact on products that improve patient outcomes.

Interested in learning more? Reach out for a confidential discussion.