(Associate) Regulatory Affairs Specialist

(Associate) Regulatory Affairs Specialist

Medtronic Cardiac and Vascular
Not Specified
Not Specified

Job Description


(Associate) Regulatory Affairs Specialist
For our location in Maastricht, the Netherlands
Careers that Change Lives
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.
A Day in the Life
In this role you'll act as the (Associate) Regulatory Operating Unit Gateway Specialist for Promotional and Collateral Material in the Europe, Middle East and Africa (EMEA) region. This means you'll:
  • Review and approve/reject requests for promotional and collateral material approval
  • Provide regulatory support/advise regarding promotional and collateral material to the EMEA Marketing, Marketing Communication and other stakeholders
  • Connect and collaborate with Regulatory & Clinical teams of the Medtronic Operating Units regarding claims used for promotional and collateral material in EMEA.

Main Job Duties & Responsibilities
  • Collaborate and pre-reviews applicable promotional and collateral materials and provides regulatory feed-back
  • Review promotional and collateral material routed through the applicable promotional material approval systems and approve/reject if applicable
  • Provide guidance and consultancy to the authors/creators of promotional and collateral material on regulatory requirements and aspects. Highlights areas where extra focus/attention is needed and recommends changes to improve operating efficiency and outputs
  • Collaborates with Regulatory and Clinical teams of the Medtronic Operating Units regarding claims used for promotional and collateral material in EMEA
  • Manages required reporting to control the effictifeness of the Promotional & Collateral Material Process and to provide input for the EMEA Market Management Review.

Must Haves
  • Education and experience preferably equivalent to a bachelor's degree in the biological, physical, engineering or medical science disciplines
  • Fluent in English, both written and spoken.

Nice to Haves
  • Relevant Experience with cross-functional work in a matrix organization, preferably in Medical Devices sector
  • Demonstrated knowledge of regulatory (clinical) requirements related to medical devices (Regulation (EU) 2017/745 (MDR), Medical Devices Directive (93/42/EEC, 90/385/EEC as amended).

Skills & Competencies
  • Effective interpersonal skills/team player
  • Embrace change
  • Detail orientated with the ability to prioritize
  • Adaptable to competing demands
  • Positive, critical and proactive attitude and approach
  • Able to work on own initiative
  • Ability to communicate effectively
  • Peer Relationship management
  • Perseverance
  • Ability to solve problems
  • Computer skilled.

We Offer
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:
  • Flexible working environment
  • Annual Incentive Plan % depending on company results
  • Pension scheme and group discount on healthcare insurances
  • Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
  • Employee Assistance Program and Recognize! (our global recognition program).

Your Answer
Is this the position you were waiting for Then please apply directly via the apply button!

Job Details

Employment Types:

Function:

IT

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. Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.

Job Source : jobs.medtronic.com

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