Principal RA Specialist
Principal Regulatory Affairs Specialist
San Francisco Bay Area (Hybrid)
$145,000-$175,000
Job Description
EPM is partnered with a publicly traded commercial-stage medical device company that has developed a differentiated treatment for pulmonary and respiratory diseases and continues to expand its global footprint. The organization is seeking a Principal Regulatory Affairs Specialist to support key regulatory initiatives across a complex Class III product portfolio. This is a highly visible role offering the opportunity to influence regulatory strategy, partner closely with cross-functional stakeholders, and contribute to products that are making a meaningful impact on patient outcomes.
Key Qualifications
* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred.
* 6+ years of Regulatory Affairs experience within the medical device industry.
* Strong FDA Class III and PMA experience required.
* Experience supporting regulatory submissions and regulatory strategy for complex medical device products.
* Prior experience with implantable, catheter-based, cardiovascular, structural heart, pulmonary, endovascular, or other highly regulated medical device technologies preferred.
* Working knowledge of FDA regulations, guidance documents, and regulatory submission requirements.
* Experience collaborating cross-functionally with Quality, Clinical, R&D, and Marketing teams.
* Strong written and verbal communication skills with the ability to influence and build relationships across functions.
Roles & Responsibilities
* Support the development and execution of regulatory strategies for new products, product modifications, and lifecycle management activities.
* Author and support PMA supplements, regulatory submissions, agency correspondence, and other regulatory documentation.
* Partner with cross-functional teams to evaluate regulatory requirements and identify potential risks and mitigation strategies.
* Provide regulatory guidance throughout product development and commercialization activities.
* Monitor evolving regulatory requirements and assess their impact on existing and future products.
* Support regulatory interactions with the FDA and international regulatory agencies.
* Contribute to global registration and market expansion activities while ensuring compliance with applicable regulations.
Benefits
* Competitive base salary and annual bonus opportunity
* Comprehensive medical, dental, and vision coverage
* 401(k) with company match
* Generous PTO and paid holidays
* Employee stock purchase program/equity opportunities
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