Please apply via LinkedIn, vs. sending me an inmail. We track candidates through LinkedIn's candidate tracking system.

Senior Regulatory Affairs Specialist, Medical Devices (Remote)

About the Role

We're looking for a motivated and experienced Senior Regulatory Affairs Specialist to join our team as a key individual contributor. In this role, you'll be responsible for developing and executing regulatory strategies to ensure our medical devices comply with global regulations. You'll work independently and collaboratively with cross-functional teams to prepare, submit, and maintain regulatory filings and documentation, playing a critical part in bringing our innovative products to market.

*Sponsorship is not available for this role

Key Responsibilities

• Regulatory Strategy: Develop and implement global regulatory strategies for new and modified medical devices, including Class II products.
• Submission Preparation: Prepare, compile, and submit high-quality regulatory filings to global health authorities.
• Compliance: Provide regulatory guidance to internal teams (e.g., R&D, Quality, Product) throughout the product lifecycle to ensure compliance with applicable regulations and standards (e.g., FDA, ISO 13485, EU MDR).
• Post-Market Surveillance: Manage post-market regulatory activities, including change control assessments, adverse event reporting (e.g., MDR/Vigilance), and regulatory audits.
• Communication: Assist with responses to global regulatory agencies, managing correspondence, and supporting agency inspections.
• Regulatory Intelligence: Monitor and interpret new and changing regulations, standards, and guidance documents, and communicate their impact to the organization.

Qualifications

• Experience:
• Minimum of 5 years of regulatory affairs experience in the medical device industry.
• Demonstrated experience with medical device submissions, specifically 510(k) and/or De Novo submissions to the FDA, and Technical Documentation for CE Marking.
• Must have ISO13485 and EU MDR experience

• Education:
• A bachelor’s degree in Bio-Medical engineering is required. An advanced degree or Regulatory Affairs Certification (RAC) is a plus.
• Skills:
• Strong working knowledge of US and international medical device regulations, including FDA 21 CFR 800-1299 and EU MDR.
• Excellent written and verbal communication skills, with the ability to create clear, concise, and scientifically sound regulatory documents.
• Effective project management, organizational, and time management skills to manage multiple projects concurrently with minimal supervision.
• Analytical and critical thinking skills to interpret complex regulatory requirements and apply them to business needs.

Salary and Benefits

• Salary Range: Up to $120,000 per year, depending on experience.
• Benefits: Competitive benefits package, including medical, dental, vision, and paid time off.