Senior Regulatory Strategy Lead – Medical Devices

Tactile Medical; New Brighton (MN); On-site; USD 94,000 - 131,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Retirement benefits

Employee stock purchase plan

Paid time off

Parental leave

Family medical leave

Job summary

Tactile Medical in Minnesota is seeking a Principal Specialist in Regulatory Affairs to guide regulatory strategy across our product portfolio. You will lead submissions (510(k), PMA, IDE) and align cross-functional teams across Engineering, Clinical, Quality, and Manufacturing.

You will influence product lifecycle decisions, monitor regulatory changes, and help ensure compliant labeling, documentation, and global filings. A strong governance mindset and leadership skills are essential.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Minimum of 7 years of medical device regulatory affairs experience, including at least 2 years hands-on experience with FDA submissions (510(k), PMA, IDE) for Class II and/or Class III devices.
• Demonstrated experience developing regulatory strategies and leading execution of complex submissions and product lifecycle activities.

Responsibilities

• Develop and execute regulatory strategies for new and existing products, aligning regulatory pathways with business objectives.
• Influence product development, portfolio planning, and lifecycle management decisions by identifying regulatory risks, opportunities, and early tradeoffs.
• Lead the preparation and technical review of regulatory submissions, including 510(k)s, q-submissions, and other global filings, as appropriate.
• Determine submission requirements and provide recommendations to ensure alignment across Engineering, Clinical, Quality, and Manufacturing.
• Ensure accurate, timely maintenance of UDI/GUDID data, licenses, registrations, listings, and post approval commitments.
• Lead the development, interpretation, and continuous improvement of regulatory policies, procedures, and SOPs, in alignment with Regulatory management and applicable document-control processes.

Skills

Regulatory strategy

FDA submissions

Cross-functional collaboration

Regulatory knowledge

Quality systems

Microsoft Office

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Job description

Tactile Medical in Minnesota is seeking a Principal Specialist in Regulatory Affairs to guide regulatory strategy across our product portfolio. You will lead submissions (510(k), PMA, IDE) and align cross-functional teams across Engineering, Clinical, Quality, and Manufacturing.

You will influence product lifecycle decisions, monitor regulatory changes, and help ensure compliant labeling, documentation, and global filings. A strong governance mindset and leadership skills are essential.