Sr. Regulatory Affairs Specialist

Medtronic•North Haven, CT

2d•$112,000 - $138,000•Hybrid

About The Position

Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle, including pre-clinical, clinical, regulatory approval, and postapproval phases. Navigate key Regulations and Guidance Documents including MDR Regulation (EU) 2017/745, UK MDR, FDA CFR 21, and guidances such as NBOG, MDCG, and FDA Deciding When to Submit a 510(k) in order to assess the Regulatory impact of product modifications, new product development projects, Issue Impact Assessments, and Supplier Change Requests, for the Core Suture portfolio. Analyze and monitor global and local regulations and standards applicable to medical products, ensuring compliance with regulatory requirements from agencies while identifying risks and opportunities. Support Manufacturing Site Inspections and Audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions. Support Globalization of Core Suture Portfolio including development and execution of regulatory strategies to support product registration and market access in US and international markets including Egypt, LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971. Position works a hybrid model, requiring the employee to be onsite in North Haven, CT 3-4 days per week. #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

Requirements

Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Biomedical Sciences, or closely related field
four (4) years of experience as a Regulatory Affairs Specialist or related occupation in regulatory affairs
Regulatory full product lifecycle for Class III medical devices, including pre-clinical, clinical, approval, and post-approval with MDR implementation
MDR Regulation (EU) 2017/745, and FDA CFR 21, and guidance including NBOG, MDCG, and FDA Deciding When to Submit a 510(k) for a Change to review projects, change controls, IIAs, and SCRs for Class III medical devices, providing regulatory assessments
Track changes for relevant standards and regulations, assess regulatory impact and provide gap assessments for regulatory requirements for product development and commercialization
Supporting manufacturing site inspections and audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions
Developing and executing regulatory strategies to support product registration and market access in US and international markets including LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971

Responsibilities

Developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market
Providing advice on regulatory requirements
Preparing worldwide submissions and negotiates their approval
Assisting with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations
Providing Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle, including pre-clinical, clinical, regulatory approval, and postapproval phases
Navigating key Regulations and Guidance Documents including MDR Regulation (EU) 2017/745, UK MDR, FDA CFR 21, and guidances such as NBOG, MDCG, and FDA Deciding When to Submit a 510(k) in order to assess the Regulatory impact of product modifications, new product development projects, Issue Impact Assessments, and Supplier Change Requests, for the Core Suture portfolio
Analyzing and monitoring global and local regulations and standards applicable to medical products, ensuring compliance with regulatory requirements from agencies while identifying risks and opportunities
Supporting Manufacturing Site Inspections and Audits, ensuring compliance with applicable requirements and supporting regulatory agency interactions
Supporting Globalization of Core Suture Portfolio including development and execution of regulatory strategies to support product registration and market access in US and international markets including Egypt, LATAM, Europe, and Asia, ensuring compliance with QSR (21 CFR 820), EU MDD/MDR, ISO 13485, and ISO 14971

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
paid sick time, as required under applicable state law