Associate Regulatory Affairs Specialist at MDU Medtronic USA Inc — Mounds View, MN

A Day in the Life

The Cardiac Ablation team within the Electrophysiology Therapies operating unit is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date the Cardiac Ablation business has transformed the lives of over 1 million patients.

This position will be based in Mounds View, MN.

The Associate Regulatory Affairs Specialist will work under the guidance of their manager and more senior regulatory specialists to provide support for the products under this business. This role will include a blend of international regulatory affairs, regulatory operations activities, and project coordination work.  Regulatory affairs work will focus on international submission activities including maintaining regulatory approvals, renewals, registrations and tender activities and assessment of device changes for registration implications.  Regulatory operations work will involve supporting regulatory systems relating to product release, economic operator verification, registration and listing, data management and initiatives to maintain integrity of CAS regulatory information, among other activities.

Roles and Responsibilities

• Understanding global regulatory requirements and how to research detailed requirements.
• Contributing to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files.
• Assessing device changes for registration implications and electronically notifying geographies of regulatory changes.
• Routing regulatory documents for approvals in electronic systems, maintaining approval information, and maintaining electronic document collections.
• Supporting requests to systems relating to product release, economic operator verification, and registration and listing.
• Participating in preparation for internal and external regulatory audits.
• Compiling materials required for new global product submissions, license renewals and change submissions. Monitoring, maintaining, and improving global regulatory tracking/control systems.
• Requesting, obtaining and maintaining FDA Certificate of Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates and various other regulatory documents.
• Keeping abreast of regulatory procedures and changes.
• Performing other regulatory duties as needed.

Must Have (Minimum Requirements)

• Bachelor's degree
• 0 years of regulatory affairs or related experience

Nice to Have (Preferred Qualifications)

• Bachelor’s Degree in a health profession, science and/or engineering field
• Experience in medical device industry
• Demonstrated technical writing skills
• Strong computer skills, including word processing, excel and project management tools and manipulating spreadsheets and creating presentations and using PowerBI tools
• Excellent organizational, project management skills
• Strong written, verbal and interpersonal skills
• Notary license

Physical Job Requirements

U.S. Work Authorization & Sponsorship

‌

Recruitment Fraud Alert

‌

Benefits & Compensation