Senior Regulatory Affairs Specialist

We are looking for a Senior Regulatory Affairs Specialist to join our team. This full-time position can be based in Arnhem, The Netherlands, or Herrenberg, Germany. As part of the Medline EU Regulatory Affairs team, this role supports the Microtek Medical BV and Malta product lines. The Sr. Regulatory Affairs Specialist:

•Assures the conformity of products sold or distributed by Microtek BV and Malta;

•Assures the compliance of products for which Microtek BV and Malta is an authorized agent in Europe in accordance with applicable European and national regulations ; and

•Acts as the Person Responsible for Regulatory Compliance (PRRC) for Microtek BV and Microtek Malta manufactured products (EU MM).

Responsibilities:

•Participates in the creation and review of technical or design files, and in the launch of new products in Europe;
•Reviews and approves regulatory labelling including product labeling, instructions for use, material
•Ensuring regulatory compliance of products sold in Europe according to applicable directives/regulations (MDD 93/42/EEC, MDR(EU) 2017/745, Swiss MedDO, UK MDR 2002, PPER 2016/425, Cosmetic regulation (EU) 2009/1223);
•Maintain data sheets, and promotional materials EU MM products sold in Europe, in accordance with European regulations;
•Complete, submit, and manage the follow up of manufacturer incident reports (MIR) to relevant European competent authorities in accordance with EU MDR 2017/745, Articles 87-90, as applicable;
•Leading and coordinating PMS activities for EU MM products ;
•Act as a business partner to product teams to support company initiatives, strategy and growth;
•Ensure the regulatory conformity of products manufactured under EU MM;
•Collect, prepares, and maintains the necessary regulatory files and information for product registration, as applicable;
•Provides the Competent Authorities with Declaration of Conformity for products manufactured under EU MM or on behalf of Microtek Medical (USA);
•Support tender requests related to regulatory inquiries and documentation/information;
•Perform regulatory watch activities; and
•Work in collaboration with European laboratories and notified bodies.

Are you our match?

• Excellent knowledge of the ISO 13485; MDR 2017/745, MDD 93/42/EEC; and related regulations as listed under “responsibilities".
•Hands-on experience in writing and reviewing regulatory submissions (e.g. MDR technical files).
•Proven ability to work collaboratively across functional departments.
Excellent written and oral communication skills; fluency in English is required.
•Strong organisational skills.
•Able to work independently and as part of a team.

No Sponsorship. 

We have everything covered:

• A comprehensive introduction by experienced colleagues - An individually tailored onboarding plan and fixed contacts so you can be off to a great start.
• Company pension plan - We increase our contributions to your pension plan throughout your employment because setting you up for a successful retirement is important to us.
• 26 days of vacation – We also focus on personal development
• A range of training opportunities - We actively support you in your professional development
• Fresh fruit, free coffee, bi-weekly team lunch and other benefits, such as Medfit Wellness Centre - So that your physical well-being is taken care of
• Employee Assistance Programme – So that your mental well-being is taken care of
• Flexible working options - To make your work flexible and productive
• International working environment - Our European headquarters is truly diverse.

Medline is committed to reducing our carbon footprint, developing responsible products, supporting our employees and local communities, and promoting high ethical standards internally and among our supplier partners. Click here to discover what Medline is doing to make healthcare more sustainable for people and the planet.