What are the responsibilities and job description for the Regulatory Affairs Manager position at Medtronic?
Position Description:
Regulatory Affairs Manager for Medtronic, Inc located in Santa Rosa, CA. Responsible for leading a team of regulatory affairs specialists while providing management and leadership to direct reports related to career development, objectives, projects, roles and responsibilities. Collaborate with cross-functional teams on product development, manufacturing operations and post market compliance activities. Lead negotiations with regulatory authorities to resolve questions and issues that arise during the product lifecycle. Develop regulatory strategies for approval in the United States, European Union, Japan, Australia, China and Canada. Assess global regulatory implications of post market changes to product design, labeling, packaging, manufacturing and sterilization. Prepare submissions for U.S. Class III and Class II devices including Investigational Device Exemptions (IDE) and IDE supplements. Responsible for Pre-Market Approval (PMA) applications, panel track and PMA Supplements, 30 Day Notices, Changes Being Effected (CBE), pre-submissions, Annual Reports, Post Approval Study Reports, IDE Annual Progress Reports, and 510(k)s. Provide regulatory review of all advertising and promotional materials. Responsible for EU Design Dossiers, Design Dossier Supplements and Technical Files. Manage global regulatory submissions including Japan Shonin, Health Canada new license or license amendment submissions and China submissions. Ensure compliance to relevant standards and FDA and other global Quality System Regulation (QSR) requirements to include ISO 13485, ISO 14971, 21 CFR parts 807, 814, 820 and 821.
Basic Qualifications:
Master’s degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 3 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field, or Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or related technical field and 5 years of experience as a regulatory affairs specialist or related occupation in regulatory affairs in the medical device field. Must possess 3 years of experience in each the following: Developing regulatory strategies for approval in US, EU, Japan, Australia, China, and Canada; regulatory implications of post market manufacturing changes; preparing regulatory submissions for US Class III and Class II devices including IDE and IDE supplements; preparing regulatory submissions EU Design Dossiers, Design Dossier Supplements and Technical Files; Pre-Market Approval (PMA) applications, PMA Supplements, FDA pre-submissions, Annual Reports, Post Approval study Reports, IDE Annual Progress Reports, 510(k)s; regulatory review of advertising and promotional materials; global submissions including Japan Shonin, Health Canada new license or license amendment submissions, and China submissions; and FDA Quality System Regulation (QSR) ISO 13485, ISO 14971, 21 CFR parts 807, 814, 820 and 821.
