Assoc Regulatory Affairs Spec [Belgium]


 

Careers that Change Lives

Bold thinking. Bolder actions. We are 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. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

A Day in the Life

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· 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 update of the Medtronic reporting systems and record keeping in electronic databases),

· Attending Field Safety Corrective Action meetings with the European regulatory affairs core team and European colleagues of the other 27 European countries,

· Close collaboration with the sales managers and sales reps. to collect/records evidence, allowing timely closure of the Benelux Field Actions,

· Follow up on Inquiries from the Competent Authority FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten) in Belgium and VWS (Volksgezondheid Welzijn en Sport), IGJ (Inspectie gezondheidszorg en Jeugd) in the Netherlands related to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping),

· Provide advisory to sales team members on product complaint handling processes and returns, to assure compliance to EU Regulations, local legislation, and Medtronic procedures,

· 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, KPI monitoring & follow up on new regulations,

Liaise with OU’s and EMEA regulatory colleagues to obtain product technical information (declarations of conformity, CE certificates, artwork etc…).

Must Haves


· Bachelor’s Degree,

· Advanced computer skills (working with Office tools e.g., Excel, PowerPoint, Word), familiarity with various accounting/reporting tools, table sheets etc.,

· Very good communicational and interpersonal skills,

· Precise thinking, with attention to details, non-chaotic style of working,

· Being interested in working with administrative, formal, and legislative tasks, with regulations, documentation etc.,

· Fluent in English and French language, both verbally and written,

· Additional German and/or Dutch language would be a huge plus (but It’s not required).

We Offer

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 insurance,

· Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract,

· Employee Assistance Program and Recognize! (our global recognition program).

About Medtronic

When joining Medtronic, you’ll become part of a company that is recognized as a Top Employer in multiple countries throughout Europe. Every day we strive to engineer the extraordinary all the while delivering excellent people experiences and practices benefitting you and your career. Read more about Top Employers .

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are engineering the extraordinary.

Our commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

Your Answer

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

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