Boston Scientific
- Location:
- Kerkrade – Nederland, Netherlands
- Salary:
- Competitive
- Type:
- Permanent
- Main Industry:
- Search Finance, Banking & Insurance Jobs
- Other Industries & Skills:
- Legal
- Advertiser:
- Boston Scientific
- Job ID:
- 130910735
- Posted On:
- 06 August 2024
Additional Locations: France-Île-de-France; Germany-Düsseldorf; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead
Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
THIS ROLE CAN BE BASED IN IRELAND, MILAN, MADRID, LONDON, PARIS, DUSSELDORF, NETHERLANDS
Purpose
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
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-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
Interested?
Please apply online with your
CV in English
#LI-CH1
#LI-Hybrid
Requisition ID: 587907
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you and look forward to connecting with you!
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