Senior Regulatory Affairs Specialist

Medtronic • Mounds View, MN

6h • $110,200 - $138,000 • Hybrid

About The Position

Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets 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 Food and Drug Administration Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Work on 510(k) submissions for US Class II medical devices. Work on EU MDD (Medical Device Directive) technical files and/or EU Medical Device Regulation (MDR) technical documentation and support the review of other Device History File (DHF) or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and Design Verification/Validation. Responsible for total product life-cycle regulatory activities including product development, obtaining approval and post market changes. Ensure product adherence to QSR 21 CFR 820, EU MDD 93/42/EEC or EU MDR 2017/745, and ISO 13485. Provide product support for patient-contacting devices requiring ISO 10993-1 for Biocompatibility, electrical devices in scope of IEC 60601 and medical device software in scope of IEC 62304. Support Outside the United States (OUS) regulatory requirements beyond the U.S. and EU. The position works as a hybrid model and will be onsite at the Mounds View, MN location 4 days per week. Relocation assistance is not available for this position. #LI-DNI. NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Requirements

• Requires a Master’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and three (3) years of experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering; OR a Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and five (5) years of experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering.
• Must possess a minimum of three (3) years of experience with each of the following:
• 510(k) submissions for US Class II medical devices
• Authoring or maintenance of EU MDD technical files & EU MDR technical documentation
• Reviewing DHF or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and/or Design Verification/Validation
• Supporting product life cycle including product development, obtaining approval/clearance and post-market changes
• QSR 21 CFR 820, EU MDD (93/42/EEC) or EU MDR (2017/745), and ISO 13485
• Regulatory support of ISO 10993-1, IEC 60601, and IEC 62304 compliance
• Supporting OUS regulatory requirements outside of the U.S. and EU

Responsibilities

• Developing regulatory strategies
• Preparing U.S. regulatory submissions
• Obtaining and maintaining approval for products and therapies to markets worldwide
• Assessing the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy
• Preparing document packages for regulatory submissions from all areas of company and inspections for Food and Drug Administration Quality Systems Regulation (QSR)
• Compiling all materials required in submissions, license renewal and annual registrations
• Recommending changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance
• Working on 510(k) submissions for US Class II medical devices
• Working on EU MDD (Medical Device Directive) technical files and/or EU Medical Device Regulation (MDR) technical documentation and support the review of other Device History File (DHF) or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and Design Verification/Validation
• Responsible for total product life-cycle regulatory activities including product development, obtaining approval and post market changes
• Ensuring product adherence to QSR 21 CFR 820, EU MDD 93/42/EEC or EU MDR 2017/745, and ISO 13485
• Providing product support for patient-contacting devices requiring ISO 10993-1 for Biocompatibility, electrical devices in scope of IEC 60601 and medical device software in scope of IEC 62304
• Supporting Outside the United States (OUS) regulatory requirements beyond the U.S. and EU

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: Mid Level