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Location: MN-Minneapolis
Position Description:
Sr. Regulatory Affairs Program Manager reporting to Minneapolis, MN. Focus on tactical, operational activities for a major program with broad or ongoing impact. Coordinate with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the RA teams to implement. Coordinate and prepare guidance for documentation packages for regulatory submissions and regulatory readiness for internal audits and inspections. Establish processes for submission material compilation, license renewal and registrations. Recommend changes for labeling, advertising and marketing literature for regulatory compliance. Establish procedures and processes for the update to EU and UK Technical Documentation and for the preparation of pre-market and post market submissions for the EU and UK whilst providing guidance on impact to US FDA and International submissions. Communicate with regulatory agencies for pre-submissions and submissions under review. Review and interpret the US FDA and international regulations to ensure compliance of the quality management system for medical devices. Understand and navigate industry regulations to include 21 CFR 820, ISO 13485 and ISO 14971, EU Medical Device Directive (EU MDD 93/42/EEC), EU Medical Device Regulation and Canadian Medical Device Regulation (CMDR). Provide guidance on regulatory strategies for medical devices in accordance with applicable FDA and international regulations leveraging knowledge of product development processes. *This position is open to telecommuting from anywhere in the United States.
Basic Qualifications:
Requires a Master’s degree in Regulatory Affairs, Biomedical Engineering, Medical Technology or related field and five (5) years of experience as a regulatory affairs specialist or related occupation in regulatory affairs. Requires a minimum of five (5) years of experience with each of the following: Regulatory Affairs for Class II and Class III medical devices; EU Technical Documentation in accordance with the EU Medical Device Directive or EU Medical Device Regulation; Pre-market and post-market medical device submissions to the EU and US FDA and International submissions; Communicating with regulatory agencies including EU Notified Bodies for the tracking of pre-submissions and submissions under review and key alignment decisions; Review and interpretation of the US FDA and international regulations for medical devices and compliance in the Quality Management System; and 21 CFR 820, ISO 13485, ISO 14971, and Canadian Medical Device Regulation (CMDR). *This position is open to telecommuting from anywhere in the United States.
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Min Salary
171800
Max Salary
237000
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 iniduals with disabilities.