1+ months

Sr. Regulatory Affairs Specialist

Medtronic
Plymouth, MN 55446
Sr. Regulatory Affairs Specialist

Location:

Plymouth, Minnesota, United States

Requisition #:

200009OW

Post Date:

Jun 19, 2020


Position Description:

**Sr. Regulatory Affairs Specialist** **, Covidien LP (a Medtronic company), Plymouth, MN. Sr. Regulatory AffairsSpecialist coordinates and prepares document packages for regulatorysubmissions, license renewal and modification. Support cross functional groupswith regulatory guidance regarding new device design development, major productchanges, pre-market and post market clinical studies. Identify US andinternational regulatory requirements for bench, electrical and clinicaltesting required for new devices and product changes. Review and recommendchanges for labeling and promotional materials. Provide regulatory guidance onpost-market activities, risk assessment and required corrective actions to meetregulatory requirements. Maintain proficiency in worldwide regulatoryrequirement and international standards for electronic medical devices,including IEC 60601-1, IEC 60601-1-2 and IEC 62304. Recommend strategies forearliest possible approvals of key international markets and ensure globalcompliance. Compile all materials required in Chinese regulatory submissionsfor Class II and Class III medical devices, including NMPA type testing, EMCtesting, and clinical evaluation dossiers. Participate in direct negotiationswith Chinese regulators and local testing centers. Professionally negotiatewith Chinese regulatory authorities on regulatory filings at the reviewerlevel. Coordinate and support technical files, 510(k) submissions and changenotifications for US/EU Class II medical devices. Coordinate improvement inregulatory aspects of the Quality System. Ensure compliance with the currentinternational regulatory procedures and where needed, generate new or update procedureswhen new regulatory requirements are determined to go into effect. Review andrecommend changes for design process and manufacturing procedures to maintainquality and regulatory compliance. Navigate Medical Device Quality Systems andRisk tools to include 21 CFR 820, ISO 13485 and ISO 14971.**


**Basic Qualifications:**

**Masters degree in Regulatory Affairs, Biomedical,Electrical or Mechanical Engineering or related field and 2 years of experiencein regulatory affairs. Must possess at least 2 years of experience with each ofthe following: assessing regulatory impact of product changes; identifyingregulatory requirements for bench, electrical and clinical testing; labelingand promotional material review for medical devices; post-market regulatoryactivities; IEC 60601-1, IEC 60601-1-2 and IEC 62304; Chinese regulatorysubmissions for Class II and Class III medical devices; negotiating withChinese regulators and local testing centers; technical files, 510(k)submissions and change notifications for medical devices; 21 CFR 820, ISO13485and ISO14971; and supporting cross functional groups with regulatory guidance.**
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-06-18 Expires: 2020-08-29

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Sr. Regulatory Affairs Specialist

Medtronic
Plymouth, MN 55446

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