Senior Regulatory Affairs Specialist (Remote - United States)

About the role

For our client, we are seeking a Senior Regulatory Affairs Specialist to join the team of a leader in the Healthcare space. This role will help shape regulatory strategy for complex medical technologies in a global, highly regulated environment. You will partner closely with cross-functional stakeholders to support market authorizations, guide submission planning, and help ensure that product claims and documentation align with applicable requirements. The position also represents Regulatory Affairs in strategic discussions that influence business decisions and speed access to market.

Responsibilities

• Lead a regulatory affairs team supporting a portfolio of restorative healing technologies
• Develop and execute regulatory strategies to support faster market authorizations
• Manage complex decision-making among cross-functional stakeholders
• Participate in global strategic meetings representing Regulatory Affairs
• Perform regulatory assessments and determine registration plans
• Compile regulatory documents according to local requirements and submit for authorization
• Review advertising materials to ensure compliance with regulatory claims

Qualifications

• Bachelor's degree or higher with 7 years of Regulatory Affairs experience, or a High School Diploma/GED with 11 years of experience in a regulated industry
• Master's degree in a scientific, engineering, regulatory, or quality discipline is preferred
• Experience with regulatory submissions, including 510(k) and EU MDR submissions, is a plus
• Familiarity with ISO 13485 and MDSAP audits is advantageous
• Experience with negative pressure wound therapy devices or electro-mechanical medical devices is beneficial

Benefits

• Comprehensive health benefits including Medical, Dental, and Vision
• Health Savings Accounts and Flexible Spending Accounts
• Disability and Life Insurance options
• Paid absences and retirement benefits
• Programs to support physical and financial well-being

Pay

$124,000 – $170,500 annually

Schedule

Remote — US based candidates only, no visa sponsorship available