Job Description
Position Description:
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
Basic Qualifications:
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; and Supporting OUS regulatory requirements outside of the U.S. and EU.
The position is located at Medtronic, Inc., 8200 Coral Sea Street NE, Mounds View, MN 55112.
Salary: $110,200 to $138,000 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 ... (truncated, view full listing at source)