Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Irvine, CA (Hybrid)
$100,000 - $120,000
Job Description
EPM Scientific is partnered with an established medical device innovator developing life-changing technologies that address critical patient needs in the cardiovascular and interventional space. As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities across the product lifecycle.
This is an excellent opportunity for a hands-on regulatory professional who enjoys working cross-functionally with R&D, Clinical, Quality, and Commercial teams while contributing directly to global product development and regulatory success.
Key Qualifications
* Bachelor's degree in a scientific discipline or related field required.
* 3-5+ years of Regulatory Affairs experience within the medical device industry.
* Strong knowledge of global medical device regulations and product development processes.
* Experience preparing and supporting regulatory submissions for international markets.
* Understanding of quality systems and their relationship to regulatory compliance.
* Ability to interpret regulatory requirements and provide guidance to cross-functional teams.
* Strong technical writing, organizational, and project management skills.
* Excellent communication and stakeholder management abilities.
* Experience with Class III medical devices preferred.
* Cardiovascular device experience is highly desirable.
Roles & Responsibilities
* Prepare, submit, and maintain global regulatory filings, registrations, annual reports, and submission amendments.
* Support interactions and correspondence with global regulatory authorities and notified bodies.
* Partner with product development and sustaining engineering teams to ensure regulatory requirements are incorporated throughout the development process.
* Interpret regulatory requirements related to product design, clinical studies, testing, labeling, and post-market activities.
* Support adverse event reporting, Medical Device Reports (MDRs), vigilance reporting, and other regulatory communications.
* Review and provide regulatory input on risk management documentation, technical reports, and related product documentation.
* Ensure product labeling remains compliant with applicable global regulations.
* Monitor evolving regulatory requirements and communicate potential impacts to the business.
* Review document change orders and support regulatory assessments for product changes.
* Participate in internal and external audits as needed.
* Maintain regulatory intelligence and contribute to continuous improvement of regulatory processes and procedures.
Benefits
* Comprehensive medical, dental, and vision coverage
* 401(k) with company match
* Competitive PTO and paid holidays
* Career development and advancement opportunities
* Collaborative and mission-driven culture
* Opportunity to work on innovative medical technologies with global impact