Boston Scientific Senior Regulator Affairs Specialist EMEA 

Netherlands, Limburg 

263845179

France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead

THIS ROLE CAN BE BASED IN IRELAND, MILAN, MADRID, LONDON, PARIS, DUSSELDORF, NETHERLANDS

This role is to support the Europe Middle East & Africa (EMEA) region in a regulatory affairs capacity. The team is dynamic and provides significant support to local in-country regulatory specialists among other departments. Within the Regulatory Affairs organization, the main objectives of the role will be to support compliance with external regulatory requirements and internal system and processes.

Responsibilities

• Providing regulatory support to the Regulatory teams throughout EMEA (Europe Middle East and Africa) region and support of some cross-divisional activities.
• Own Regulatory related NCEPs and CAPAs for the region.
• Local Actor Administrator (LAA) for BSC EUDAMED account. Own process around economic operator registrations in EUDAMED. Act as local EUDAMED SME.
• Own process around Authorised Representative verifications as per Article 11 EU MDR 2017/745. Perform verifications as required.
• Regional SME for the Regulatory Requirements process. Assist local teams in using the process and ensuring all activities are completed in a timely fashion to prevent compliance gaps.
• Support all regional and Corporate audits, both internal and external.
• Additional process support as required.
• Supporting regulatory operations activities in conjunction with global regulatory operations.
• Support global advocacy efforts in monitoring regulation changes across the region.
• Suggest opportunities to add efficiencies to existing processes as part of department’s VIP goals.

Skills and experience required

• Minimum of a Bachelor’s degree or equivalent work experience
• Minimum of 5 years’ experience in Quality/Regulatory Affairs or a related discipline within the medical device, IVD, pharmaceutical or healthcare industries
• Strong knowledge of quality system processes
• Good listening and communication skills, with ability to transfer knowledge efficiently.
• Demonstrated high degree of integrity, professionalism, and the ability to establish credibility.
• Flexible in approach to problem solving, agile learner.

This is a Hybrid work mode role, so you will be required to go into the offices 2-3 days per week

Please apply online with your