Principal Regulatory Specialist

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

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

This role is accountable for ensuring regulatory compliance across the product lifecycle for the company’s current product portfolio while proactively enabling innovation, market expansion, and business growth.

Acting as a trusted advisor to cross functional leaders, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

This individual contributor role is accountable for ensuring regulatory compliance across the product lifecycle while proactively enabling innovation, market expansion, and business growth. Acting as a technical advisor to cross-functional partners, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

Accountabilities & 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.
• Monitor, assess, and communicate regulatory changes, translating requirements into actionable guidance for stakeholders.
• Partner with Quality and Operations to support audits, inspections, recalls, and remediation activities, ensuring effective regulatory risk management.
• Provide regulatory review and technical guidance for labeling, promotional materials, and advertising to support compliance with applicable regulations.
• Act as a strategic regulatory partner to R&D, Quality, Clinical, Manufacturing, Marketing, and Supply Chain teams.
• Mentor and coach regulatory team members and cross-functional partners, strengthening overall regulatory capability within the organization.
• Deliver training and education on regulatory requirements, trends, and best practices to promote an enterprise-wide compliance culture.
• Collaborate with external consultants, notified bodies, and legal counsel to resolve complex regulatory challenges.
• Ensure timely execution and completion of regulatory activities to support product launch timelines and business milestones.
• Maintain accurate, compliant regulatory documentation and systems.
• Uphold the highest ethical standards, confidentiality, and integrity in all regulatory interactions.
• Perform other duties as required to support the regulatory function and business objectives.

Qualifications

Required

• 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.

Preferred

• Regulatory affairs certification.
• Experience with electrical-mechanical devices (IEC 60601).
• Experience with software as a medical device and/or software in a medical device (IEC 62304).

Knowledge & Skills

• Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant regulations, requirements and standards related to medical devices.
• Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software.
• Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.
• Possess exceptional written and verbal communication skills in preparing multi-stakeholder documents and presentations (e.g., scientific, clinical/medical, regulatory reviewer).
• Strong knowledge in medical device Design Controls and Risk Management.
• Capable of managing multiple projects and complex timelines in a team environment.
• Cross functional collaboration skills needed to foster alignment.
• Excellent influence and impact skills.
• Strong analytical and critical thinking skills.
• Strong cross-functional skills to foster alignment.

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

US Pay Range

$93,600 - $131,040 USD

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