Job Description

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This range is provided by Arevna. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$140,000.00/yr - $170,000.00/yr

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Senior/Principal Regulatory Affairs Specialist

Remote

A leading Ophthalmic medical device company is seeking an experienced Principal (or Specialist) Regulatory Affairs professional to join their team. This is a hands-on role for a regulatory expert who will directly prepare, submit, and manage regulatory filings while collaborating cross-functionally on product development and approvals. Its an impactful opportunity to play a central role in bringing innovative surgical and medical technologies to market.

About the Role

As a Principal/Specialist Regulatory Affairs professional, youll take ownership of the preparation and management of regulatory submissions, ensuring compliance with FDA and international requirements. Youll be responsible for drafting and submitting complex regulatory files, conducting direct communications with the FDA, and providing specialized regulatory support across the product development lifecycle.

Key Responsibilities

• Prepare and submit 510(k) applications for FDA clearance
• Prepare and submit IDE applications to support clinical trials
• Utilize FDA eSTAR for efficient electronic submissions
• Lead and document communications with the FDA, including Q-Sub and pre-sub meetings
• Maintain accurate technical documentation and regulatory records
• Collaborate with R&D, Quality, and Clinical teams to align regulatory requirements throughout product development
• Contribute regulatory expertise to both strategy and direct submission execution

Qualifications

• Bachelors degree in a science, engineering, or healthcare-related field
• 5+ years of regulatory affairs experience for medical devices
• Proven experience preparing and managing 510(k) and IDE submissions
• Strong skills using FDA eSTAR and managing FDA communications (Q-Subs, meetings, responses)
• In-depth knowledge of FDA regulations, QSR/QMSR, ISO 13485, and EU MDR
• Excellent written and verbal communication abilities; effective collaborator across specialties

Whats in it for you?

• Competitive compensation and comprehensive benefits
• Medical, dental, vision, 401(k) with company match, and more
• A visible, hands-on regulatory role at the core of new product development

If this sounds like your next career move, apply now!

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Consulting, and Administrative

• Industries

  Medical Practices and Medical Equipment Manufacturing

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