Role Title: Principal Regulatory Affairs Specialist
Location: Palo Alto, CA (Hybrid Role)
Responsibilities
Act as the technical regulatory lead on core product development teams.
Develop global regulatory strategies for new and modified products.
Prepare and submit Pre-subs/PMA/IDE Submissions and supplements for new products and product changes.
Provide support for currently marketed products including review of labeling, promotional material, and product changes.
Interpret new or existing regulatory requirements and ensure compliance.
Keep updated with changes in agency regulations and train stakeholders accordingly.
Review and approve internal engineering documentation and change orders.
Provide business and product information to international regulatory staff.
Mentorship within the RA team and willingness to take on additional responsibilities as assigned.
Requirements
Minimum of a Bachelor's degree, preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification such as RAC from the Regulatory Affairs Professionals Society is a plus.
Minimum of 5+ years of regulatory experience within the medical device cardiovascular industry, with expertise in Pre-submissions, PMA submissions, and hardware/software regulatory requirements.
Ability to manage multiple priorities with minimal oversight.
Proven track record in formulating successful regulatory strategies meeting approval timelines while maintaining quality.
Strong understanding of US and major market regulatory requirements, project management, and negotiations.
Experience with medical device hardware and software regulations.
Excellent interpersonal and communication skills, both oral and written.
Self-motivated with strong time management skills and a collaborative team player.
Seniority level
Associate
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
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