Regulatory Affairs Manager

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Biotechnology and Medical Devices organization, based in Antwerpen Belgium.

is a new and upcoming party in the Medical Devices / IVD niche. The company is growing quickly and is expanding its territory by the day.

ROLE DESCRIPTION

My client gives an opportunity to work in a highly innovative, new and growing diagnostics business. This senior level position reports in my client Q&R Director. The function supports regulatory activities for companion and complementary diagnostics in Europe, Middle East and Africa (EMEA).

RESPONSIBILITIES

• Support the Q&R Leader for regulatory activities for In Vitro Diagnostics (IVD) in development and/or marketed pharmaceutical products. Provide guidance and support to project teams regarding regulatory compliance issues.
• Prepare or review regulatory strategies and plans.
• Create or coordinate STED submission files and design dossiers for EMEA. This might involve managing contractors or interacting with external development parties.
• Interact with notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
• Manage external standards, including the monitoring of changed/new regulations, guidelines and standards, coordinating the review with the subject matter expert, manage the external standards database.
• Create and submit US State License renewal and extension files. Follow up with the US State health authorities for a smooth continuation of the lab licenses.
• Perform copy review of promotional and scientific material to verify compliance with the approved claims.
• Evaluate regulatory impact of product changes.
• Support the EU Authorized Representative with registration of IVD medical devices and FCA/Recall-letters to Competent Authorities.

REQUIREMENTS

• Bachelors, preferably Masters, degree in Pharmaceutical, Biomedical Sciences or equivalent with 10 years business experience.
• A minimum of 4-6 years experience with EU conformity assessments and regulatory strategies for In Vitro Diagnostics (IVD Dir 98/79/EC), preferably for molecular diagnostic assays. Experience with 510(k)/PMA (US) or pharmaceutical development process is recommended.
• Working language is Dutch and English; mastering other major European languages is an asset.
• Empathic, dynamic personality with eye for detail.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.