Sr Regulatory Affairs Spec

Medtronic•Boston, MA

20h•Onsite

About The Position

The Senior Regulatory Affairs Specialist (Sr. RAS) at Medtronic is responsible for collaboratively planning and executing regulatory activities for the Basic Energy and Access and Instrument product portfolio. This involves preparing and submitting regulatory documents like 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting the implementation of the EU Medical Device Regulation (MDR). The Sr. RAS translates regulatory requirements into project or product requirements and works with various departments to ensure timely and accurate regulatory deliveries. The role requires comprehensive experience across the entire regulatory life cycle of medical devices and a strong background in reviewing advertising and promotional materials. Initially, the focus will be on regulatory sustaining activities, with potential for new product development responsibilities in the future.

Requirements

Bachelor’s degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry OR a master’s degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Knowledge of FDA and EU MDR requirements
Experience of working with all classification of product in the U.S and/or EU.
Design Dossier and/or Technical Documentation experience
Technical Writing
International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR)
Product Labeling requirements and standards
May have practical knowledge of project management
Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.

Responsibilities

Provide strategic and technical regulatory guidance to support design and manufacturing sustaining covering both domestic and international requirements.
Prepare 510(k) submissions/ letter to file, change notices and updates to technical documents to support US and EU markets.
Interact and negotiate with regulatory authorities during product development and review processes.
Share business and product information with international regulatory teams to inform strategy and communicate requirements to the business team.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
Review and approve promotional and advertising materials for compliance.
Stay up to date on domestic and international regulatory requirements, guidelines, and standards.
Participate in internal and external audits as required.
Maintain regulatory documentation to ensure compliance.
Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
Monitor regulatory procedures and changes.
Interact directly with regulatory agencies on defined matters as needed.
Contribute to continuous improvement initiatives and process optimization within RA
Perform additional duties as assigned.

Benefits

Competitive Salary
Flexible Benefits Package
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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Paid sick time (for temporary employees, as required under applicable state law)