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. To apply, visit https://medtronic.wd1.myworkdayjobs.com/MedtronicCareers/, select Req.# R20125. No agencies or phone calls please. Medtronic is an equal opportunity employer committed to cultural diversity in the workplace. All individuals are encouraged to apply.