Senior Regulatory Affairs Specialist
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Mervue • Ireland
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Salary
💰 €61,440 - €92,160 per year
Job Level
About the role
- Implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes.
- Ensuring high-quality results through mentorship and guidance to team members.
- Collaborating closely with cross-functional partners like R&D, clinical, operations, and marketing.
- Representing the company in discussions with regulatory bodies and industry groups.
- Directing or performing preparation of document packages for regulatory submissions.
- Leading or compiling materials for CE-Mark and FDA submissions, license renewals, and annual registrations.
- Working with engineers and technical experts to develop robust regulatory strategies.
- Recommending changes for labelling, manufacturing, marketing, and clinical protocol reports for regulatory compliance.
- Keeping abreast of regulatory procedures and changes.
Requirements
- Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices.
- A Regulatory Affairs qualification is desirable, but not mandatory.
- Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
- You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
- Strong technical knowledge.
- Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
- Experience with software and hardware medical devices.
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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory submissionsregulatory complianceCE-Mark submissionsFDA submissionsdocument preparationtechnical knowledgeexperience with medical devicesexperience with pharmaceuticalsexperience with software and hardware medical devices
Soft Skills
mentorshipguidancecollaborationteam playerproactive workcommunication
Certifications
Regulatory Affairs qualification