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About Medtronic
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
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
Responsibilities
• 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
• 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
Must Haves
• 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
• 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
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.
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.
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