Senior Regulatory Strategy Leader – MedTech

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

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.