Principal Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Leading the preparation and submission of 510(k) applications along with other regulatory filings for Software as a Medical Device (SaMD).

• Developing and implementing global regulatory strategies for product registrations in the US, EU (MDR), and Canada.

• Assisting international regulatory teams with product registrations within the Custom Smiles Portfolio.

• Ensuring adherence to global regulations and reviewing technical and software documentation for submissions.

• Collaborating across functions to incorporate regulatory requirements into product development.

⛳️ Requirements

• Bachelor’s Degree or higher with seven (7) years of regulatory affairs experience in medical devices, or a High School Diploma/GED with eleven (11) years of regulatory affairs experience in medical devices.

• Minimum of five (5) years of experience with Software as a Medical Device (SaMD).

• Proven experience in authoring 510(k) submissions for SaMD.

• Background in supporting regulatory submissions in the United States and European Union.

• A Master’s degree in Regulatory Affairs (considered an additional qualification).

• Experience in supporting regulatory submissions in Canada (considered an additional qualification).

• Regulatory Affairs Certification (RAC) (considered an additional qualification).

• Experience with dental or orthodontic medical devices (considered an additional qualification).

• Familiarity with applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirements (considered an additional qualification).

• Experience in preparing and reviewing regulatory documentation and submissions (considered an additional qualification).

• Ability to communicate regulatory requirements, risks, and outcomes through written reports, presentations, or discussions across functions (considered an additional qualification).

• Experience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to facilitate regulatory activities (considered an additional qualification).

🏝️ Benefits

• Medical

• Dental & Vision

• Health Savings Accounts

• Health Care & Dependent Care Flexible Spending Accounts

• Disability Benefits

• Life Insurance

• Voluntary Benefits

• Paid Absences

• Retirement Benefits