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Regulatory Affairs Specialist, French speaking, Netherlands based
To support our Regulatory Affairs (RA) field actions in the Netherlands we are currently looking for a fulltime Regulatory Affairs Specialist. You are an excellent communicator and enjoy supporting the commercial business units with your advisory and instructions.
This is a great challenge to get onboard in an experienced RA Benelux team. Your dedicated task is to support and advice the sales team to assure compliance with all local Benelux legislation applicable to Post Market Surveillance as well as competent authority, hospital customer engagement and tenders.
Come and join our Medtronic promotion on environmental stewardship!
The health of the planet is vital to the health of society. Therefor we’re reducing our use of the natural resources we all rely on and invest in renewables to sustainably power our global operations and set the goal to be carbon neutral in our operations in 2030.
Further details you can find on https://www.medtronic.com/us-en/about/citizenship/promoting-environmental-stewardship.html
Field Actions and Product Hold
• Act as the responsible person within Regulatory Benelux in the preparation, execution and follow up of field safety corrective actions and product holds. (this includes the correct update of the Medtronic reporting systems and record keeping in an electronic database).
• Attending Field Safety Corrective Action meetings with the European regulatory affairs core team and European colleagues of the other 27 European countries.
• Organize weekly follow-up meetings with the sales managers and the sales representatives of Medtronic sales force at the hospitals within the Benelux.
• Ensure a close collaboration with sales reps. to collect records/evidence allowing the closure of the field action.
Competent authorities Inquiries
Follow up on Inquiries from the competent authority Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten, #FAGG in Belgium and Volksgezondheid Welzijn en Sport, #VWS, Inspectie gezondheidszorg en Jeugd, #IGJ in the Netherlands related to #vigilance activities (this includes updating of the Medtronic reporting systems and record keeping).
Complaint Handling Support
Provide advisory to the sales team members on the product complaint handling process and returns to assure compliance to Netherland legislation, regulations, and Medtronic procedures.
Quality & Regulatory Support
To support the Medtronic matrix organization you have to support multiple #Regulatory & Quality activities within the Benelux, related to Supplier Management, Distributor Management, Document Control, Key Performance Indicators (KPI) monitoring, approve local marketing projects and follow up on new regulations
Support Tender & Customer Requests handling
• Liaise with Operating Units and EMEA plant regulatory colleagues to obtain product technical information (declarations of conformity, #CE certificates, artwork etc.)
• Check different databases to obtain the necessary data/information and provide feedback to tender team, sales teams, and customers.
A Day in the Life
We offer you a position, where you can utilize your current RA experience and developing into a sought-after advisor when it comes to Benelux RA matters. You will have the opportunity to become a valued specialist and building strong relationships to the Business in Medtronic, Benelux
This is a position that potentially can include more responsibilities and impact in EMEA RA matters.
• Bachelor’s degree
• 3+ years of experience working in a Regulatory Affairs area
• Fluent in English and preferred French
• Additional German and/or Dutch preferred
• Ability using Microsoft Office Suite and handling knowledge databases on a super user level
• You have an eye for detail and enjoys delivering quality in your work and proceed with integrity
• As an advisor you are an outstanding communicator and thrive to be effective and balancing time vs. deadlines
• You enjoy Continuous Learning are being proud to deliver quality and are confident to share smarter ways of working into your team and present innovative ideas on RA professional area
Is this the position you were waiting for? Then please apply directly via the apply button!
At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it’s the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veterans, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer — your unique perspectives, talents and contributions — we can live up to the promise of our Mission.