Regulatory Affairs Specialist
Medtronic is looking for a Regulatory Affairs Specialist
Careers that Change Lives
At our Bakken Research Center in Maastricht, about 220 clinical researchers, scientists and technical engineers cooperate closely with medical specialists in and outside of Europe to develop new and improve existing therapies in Cardiac Rhythm Disease Management and Cardiovascular Surgery. Our broad range of clinical services includes international project management, statistical advise, IT support and medical writing, which makes us Medtronic’s authority on clinical research outside of the US.
A Day in the Life
- Provides guidance, leadership and consultancy to the SBUs and other stakeholders regarding regulatory issues, interpretation and questions. Highlights areas where extra focus/attention is needed and recommends changes to improve operating efficiency and outputs
- Manages submissions to notified body and controls project deliverables, timelines, communication and performance to ensure timely and predictable CE marking
- Collaborates with the notified body on projects/products at reviewer level, to ensure a timely review
- Represents CE market access team, collaborates with other internal stakeholders on projects
- Develops proficiency in EU medical device regulatory landscape
- Bachelors degree required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
- Relevant Experience with cross-functional work in a matrix organization
- Fluent in English, both written and spoken
- Interpersonal Skills
- Organizational Skills
- Embrace change
- Detail orientated with the ability to prioritize
- Adaptable to competing demands
- Ability to communicate in action-oriented language
- Planning & Project Management
- Peer Relationships
- Manage Vision & Purpose
- Strong communication skills to different organizational levels & stakeholders
In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
Also a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:
- 28 holidays;
- Possibility to purchase 8 extra vacation days;
- Flexible working environment;
- Annual Incentive Plan % depending on company results;
- Pension scheme and group discount on healthcare insurances
- Tax advantages on commuting, fitness plan, bicycle plan;
- Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
- Employee Assistance Program and Recognize! (our global recognition program)
- Private Lease possibilities
Is this the position you were waiting for? Then please apply directly via the apply button!
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.