Associate Regulatory Affairs Specialist

Medtronic • Mounds View, MN

2d • Onsite

About The Position

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. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 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.

Requirements

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

Nice To Haves

• 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
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level