Sr. Regulatory Affairs Specialist

Medtronic • Lafayette, CO

1d • $92,000 - $138,000

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist. Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries. The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally.

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

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees