Sr Regulatory Affairs Spec
About The Position
At Medtronic, you can begin a life-long career of exploration and innovation, helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This Senior Regulatory Affairs Specialist role is for individuals with experience in regulatory compliance and an interest in cutting-edge medical technologies. The products involved include different technologies (active and non-active, hardware and software) and are sold in over 30 countries. The specialist will be part of the US Regulatory team, reporting to the Regulatory Affairs Manager, and will support a wide range of activities with frequent interactions with corporate teams in the US and globally. Medtronic leads global healthcare technology, addressing challenging health problems with a mission to alleviate pain, restore health, and extend life. The company is comprised of a global team of 95,000+ people, who are engineers at heart, dedicated to experimenting, creating, building, improving, and solving to generate real solutions for real people. Medtronic fosters a dynamic and inclusive culture, valuing diverse perspectives and a commitment to life-long learning, aiming to build a better future and transform lives through extraordinary technologies and insight-driven care.
Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Nice To Haves
- Experience in the medical device industry
- Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
- Excellent attention to details, proactive approach and ability to work independently
- High learning agility and ability to work under pressure
- Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
- Write, update and maintain technical documentation
- Review promotional material for accuracy and compliance
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
Benefits
- Competitive Salary and 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
