**Job Title:** Regulatory Affairs Director - Medical Devices

**Location:** Minneapolis, MN / Saint Paul, MN

**Type:** Full-time/Permanent

**Experience Required:** 8 years+ experience working in regulatory affairs

**Description:**

The person selected should have strong knowledge of FDA regulations, guidance documents, and requirements for device submissions. He or she should also possess strong communication skills and be able to effectively communicate with various stakeholders including physicians, patients, manufacturers, payers, and regulators. In addition, he or she should possess strong technical writing skills and be able to translate complex information and scientific data into accessible language. Finally, the ideal candidate should have strong leadership qualities and be able to work well with a team.

**Responsibilities:**

• Work directly under the supervision of the Vice President, Regulatory Affairs and Quality Management
• Manage the day-to-day activities of the Regulatory Affairs department including organizing meetings, coordinating schedules, reviewing and approving expense reports, managing the workflow of internal and external clients, ensuring compliance with industry standards, and preparing regulatory filings
• Assist the Vice President, Regulatory and Quality Management with planning and executing company initiatives with respect to regulatory responsibilities
• Prepare and submit regulatory filings to FDA and MHRA (UK)
• Maintain current knowledge of US and EU guidelines and legislation relating to medical device regulation
• Oversee all aspects of premarket approval applications and post-market surveillance programs
• Ensure regulatory compliance with all applicable laws, statutes, rules, regulations, and guidances pertaining to medical devices