Senior Regulatory Affairs Specialists

We anticipate the application window for this opening will close on - 11 Apr 2025

Position Description:

Senior Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Responsible for developing regulatory strategies, preparing U.S, EU, and international submissions, and obtaining and maintaining approval for products and therapies to markets worldwide for Class I, II and III devices. Support Market Expansion and product development teams by preparing regulatory strategies and identifying regulatory requirements for submissions to ensure the efficient approval and registration of products worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for FDA Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations for submissions. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Communicate with regulatory agencies and Notified Body and serve as regulatory liaison on the project team throughout the product lifecycle. Develop MDD and MDR design dossiers, technical files and change notifications and Design History Files for Class I, II and III devices. Work on Common Submission Dossier (CSDT), Device master file (DMF) and Japan shonin. Responsible for total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval. Navigate worldwide regulatory requirements and adhere to regulations including FDA medical device regulations like 21 CFR 800, 801, 803,814, Japan’s Pharmaceuticals and Medical Devices Act, EU Medical Device Directive 2007/47/EC, EU Medical Device Regulation (EU) 2017/745, Australia’s Therapeutic Goods Administration (TGA). Ensure product adherence to government and industry standards including Quality System Regulation (QSR 21 CFR 820), ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485 and ISO 14971. *Multiple positions available. **This position is open to telecommuting from anywhere in the United States. #LI-DNI.

Basic Qualifications:

Master’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field. Requires two (2) years’ experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering.  Experience must include two (2) years post-bachelor’s progressive experience with each of the following: MDD/MDR design dossiers, technical files and change notifications, and Design History Files for Class I, II and III medical devices; Common Submission Dossier (CSDT), Device master file (DMF) and Japan Shonin; Total product life-cycle regulatory activities to include pre-clinical, clinical, approval and post-approval; 21 CFR 800,801, 803,814, Japan’s Pharmaceuticals and Medical Devices Act, EU Medical Device Directive 2007/47/EC, EU Medical Device Regulation (EU) 2017/745, Australia’s Therapeutic Goods Administration (TGA) Regulations); QSR 21 CFR 820, ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485, and ISO 14971.

The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432 and is open to telecommuting from anywhere in the United States.

Salary: $114,400 to $133,200 per year

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans