Regulatory Affairs specialist EU - BD Life Sciences

Created by: Becton Dickinson
Added: 26.02.2020

Advert description

The Regulatory Affairs Specialist BD Life Sciences, EU, is reporting directly to the RA Manager, Regulatory Affairs Europe and is part of the RA EMEA BD Life Sciences department and the RA EU team BD Life Sciences. This position will mainly focus on providing regulatory support for BD Life Sciences products in Europe/CEE and Israel in relation to the new MDR and IVDR regulation.
You will assess the impact of the EU regulations, EU IVDR and EU-MDR on the product registrations in the Europe/CEE and Israel and ensure that the local regulatory requirements are met to market the products in this region.

 

Your responsibilities:

 

  • You process regulatory updates, amendments and notifications for legacy and new BD Life Sciences products in EU/CEE and Israel and provide responses in a timely manner. Where applicable, requests are to be made through the applicable (i.e. eGPS) system;
  • You coordinate timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale and Certificates of Exportability. Interfaces hereto with the applicable regulatory organization within BD or regulatory agencies directly;
  • You interface with OEM's to collect specific registration information as needed;
  • You maintain the EU CE-marking databases;
  • You coordinate and support the provision of a variety of statements to help the business;
  • You review and respond to internal and external customer requests for regulatory documents;
  • You follow up on all required translations for labels and IFUs for the EU/CEE and Israel;
  • You develop and maintains departmental procedures (SOP's and work instructions) for European and international product registrations (CEE and Israel) and/or regulatory activities as needed;
  • You have a good understanding or desire to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices and medical devices which may impact the BD Life Sciences businesses;
  • You recognize and propose continuous process improvements.
  • You manage small projects individually and provide support to other projects as appropriate.
  • You provide other duties and assignments as required.

 

Your profile:

 

  • You have a related degree in a higher education
  • You are industry/function-specific certified
  • You have 1-2 years or more related life-science or medical devices industry experience.
  • You are a demonstrated self-starter, and highly motivated.
  • You have amazing analytical and problem-solving skills and are great with planning and organizing
  • You are able to juggle multiple tasks and to prioritize and schedule work to meet business needs.
  • You have excellent written and verbal communication skills including the ability to communicate across cultures; work with others in a team environment; and effective interactions with technical personnel (scientific and legal).
  • You have an eye for details
  • You are fluent in English (both written en verbal). Any other European language is a plus.
  • You are willing to travel up to 10%

 

What can you expect from us?

 

  • A varied function with international contacts within a company with an important social contribution in a value-driven organization.
  • An informal working atmosphere, dynamic corporate culture and an environment that lets you grow and develop.
  • An attractive remuneration package

 

Interested? Hit the "apply button"!

 

BEL Erembodegem - Dorp 86

Specific details

Type of Contract Full time
Preferred Education Bachelor's
Level of Experience 2-5 years

Location

Belgium, Europe
Erembodegem, Flemish Region