Staff Regulatory Affairs Specialist

Remote – US based candidates only, no visa sponsorship available

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Responsibilities

• Lead regulatory representative on development teams, communicating regulatory requirements
• Develop global regulatory strategies for new and modified products
• Monitor and interpret current/new regulatory requirements and international standards
• Ensure compliance with FDA Medical Device Regulations and EU-MDR
• Independently identify and resolve regulatory issues, escalating as necessary
• Provide effective communication and timely responses to internal customers
• Drive continuous improvement in processes and customer satisfaction
• Mentor high-performing regulatory talent
• Ensure adherence to FDA Quality Management System requirements
• Collaborate on US FDA 510(k) and Technical File creation and remediation
• Draft comprehensive regulatory impact assessments for design changes

Requirements

• Bachelor's Degree in a scientific discipline (e.g., Chemistry, Life Sciences, Biology) or equivalent vocational qualifications
• 8 years experience with a B.S. or 6 years with an M.S. in regulatory submissions for medical devices
• Familiarity with 21 CFR 820, ISO 13485, EU Medical Devices Directive (93/42/EEC) and/or IVD Directive (98/79/EC)
• Strong project team collaboration skills
• Ability to manage multiple priorities with minimal oversight

Benefits

• Opportunity to work on breakthrough medical innovations
• Supportive culture encouraging continuous improvement and compliance
• Exposure to global regulatory strategies
• Mentorship opportunities for professional growth
• Opportunities to engage with cross-functional teams

Pay

$100,000 – $130,000 annually