Medical Device Regulatory Specialist

Michael Page; Vlaams-Brabant; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Internationale exposure

Opstart- en ontwikkelingsmogelijkheden

Vast contract

Job summary

Michael Page zoekt een Regulatory Affairs Specialist, Medical Devices, ter versterking van zijn Regulatory Affairs team. Je werkt nauw samen met Quality, Clinical Affairs en internationale stakeholders.

Je registreert medische apparaten in toegewezen markten, bereidt en dient regulatory documenten in, en bewaakt regulatory compliance gedurende de productlevenscyclus. Daarnaast analyseer je marketingmaterialen op regulatory impact en fungeer je als contactpunt voor fabrikanten en autoriteiten.

Qualifications

• Bachelor- of Masterdiploma in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs of een gerelateerd vakgebied.
• 1–3 jaar ervaring in Regulatory Affairs binnen medische apparaten.
• Goede kennis van MDR, productregistraties en regulatory documentation.
• Proactief en georganiseerd, met sterke analytische en communicatieve vaardigheden.
• Comfortabel samenwerken met internationale teams en stakeholders.

Responsibilities

• Coördineer registraties van medische apparaten in aangewezen markten.
• Voorzie, beoordeel en dien regulatory documenten in bij interne en externe stakeholders.
• Ondersteun regulatory compliance en beheer veranderingen door de productlevenscyclus.
• Beoordeel marketingmaterialen op regulatory implicaties.
• Volg regelgeving en communiceer relevante updates intern.
• Dien als aanspreekpunt voor fabrikanten, distributeurs en bevoegde autoriteiten.

Skills

Regulatory MDR kennis

Education

Bachelor/Master Life Sciences

Job description

Wat:

Frequentie: Dagelijks Wekelijks

Our client is an international healthcare organisation active in the medical device industry. The company develops and distributes products that support healthcare professionals and patient care across several international markets.

To strengthen its Regulatory Affairs team, the organisation is looking for a Regulatory Affairs Specialist who will work closely with Quality, Clinical Affairs and other international stakeholders.

Medical Device Regulatory Specialist

As a Regulatory Affairs Specialist, Medical Devices your responsibilities are:

• Coordinate medical device registrations across assigned international markets
• Prepare, review and submit regulatory documentation with internal and external stakeholders
• Support regulatory compliance and manage changes throughout the product lifecycle
• Review marketing materials and assess their regulatory implications
• Monitor regulatory developments and communicate relevant updates internally
• Act as a contact for manufacturers, distributors and competent authorities

Profiel

A successful 'Regulatory Affairs Specialist, Medical Devices' should have:

• Bachelor's or master's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field
• Between 1 and 3 years of Regulatory Affairs experience within medical devices
• Good knowledge of MDR, product registrations and regulatory documentation
• Proactive and organised, with strong analytical and communication skills
• Comfortable working with international teams and different stakeholders

Aanbod

Our customer offers you:

• A permanent contract with a competitive salary package
• Attractive extra-legal benefits
• International exposure within the medical device industry
• Structured onboarding and development opportunities
• The possibility to build a long-term career in Regulatory Affairs