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:
1. Directs or performs coordination and preparation of document packages for regulatory submissions.
2. Supports change control activities to support global approval and implementation of product and process changes.
3. Leads or compiles all materials required in submissions, license renewal, and annual registrations.
4. Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
5. Works with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
6. Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
7. Keeps abreast of regulatory procedures and changes.
8. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
9. May have direct interaction with regulatory agencies on defined matters.
10. Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
11. Identifies and develops best practices within the Regulatory Affairs Department, including continuous development initiatives.
Key Skills & Experience:
1. Level 8 Honor's Degree Science or Engineering bachelor's degree/master's with a minimum of 4 years of relevant experience.
2. A Regulatory Affairs qualification is desirable, but not mandatory.
3. Regulatory experience in Medical Devices, Pharmaceuticals, or similar regulated industry is required.
4. A dynamic team player who can work effectively and pro-actively on activities both individually and in teams.
5. Strong technical knowledge.
6. Skilled in thinking critically and making sound decisions.
7. Ability to comprehend principles of engineering, physiology, and medical device use.
8. Collaborate with global cross-functional teams and create alignment with team members.
9. Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745, and international regulatory agency requirements.
10. Provide guidance, coaching, and training to other employees within job area.
11. Set high standards and drive accountability in the execution of your responsibilities, and model ethical behavior.
12. Ability to effectively manage multiple projects and priorities.
Medtronic offers a competitive salary and flexible benefits package.
About Medtronic:
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
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