Regulatory Affairs Specialist

Within Akkodis (previously named AKKA and Modis) we are looking for a Regulatory Affairs Specialist to coordinate multiple small and big projects in our team working in the pharmaceutical industry.

Who are we? With more than 1.000 people working in Belgium and 50.000 worldwide, we are the biggest consultancy company focusing on innovation within engineering projects in sectors like pharma, food, automotive, energy, aerospace, digital,... With our many trainings and strong follow-up, we prepare our consultants to be true experts in their field.

Job description

• You prepare and submit product technical documentation or premarket submissions to obtain or to maintain market authorization for our CE-marked, FDA-cleared, and custom-made medical devices. You communicate clearly with internal teams and stakeholders about these submissions and ensure that agreed timelines are respected.

• You interface with regulatory agencies, such as the FDA, Notified Bodies, and Competent Authorities, and respond to their questions within strict timelines.

• You guide and review development and engineering activities to assure regulatory compliance during new product development and product changes. You create and maintain the technical documentation of these products.

• You review and approve labeling and marketing material of the medical devices within your portfolio.

• You interpret and monitor regulations, guidances, and standards and translate them into efficient internal procedures and processes.

Your profile

• Master's degree in a relevant scientific discipline (including engineering, pharma, biomedical sciences, law)

• Minimum of 3 years of regulatory or equivalent experience within the medical device industry

• Experience with the interpretation and application of ISO 13485, Quality System Regulations, Medical Device Directives, and Medical Device Regulation

• Preferably familiar with medical device (hardware and software) development, risk management, labeling requirements, or clinical evaluation

• Experience in implementing regulations into workable and efficient processes

• Excellent technical written and communication skills in English are a must, knowledge of Dutch is an asset

• Good organizational skills with a pragmatic, hands-on, and flexible approach to your work

• Able to keep a high-level overview of ongoing priorities and can easily coordinate multiple projects within a global context.

• Must be proficient in MS Office products, including Word, Excel, and PowerPoint

What do we offer:

• A permanent contract (freelance is an option)

• Doing multiple big innovation projects at many great companies and industries = a lot of variety!

• A strong follow-up during your projects by your Business Manager and HR Business Partner, focusing on career development and training.

• Flexible working hours and working-from-home possibilities (depending on projects)

• Company car and fuel card

• Insurances

• Many trainings, e.g. PMI, lean six sigma, software tools, time management,...

• Many fun activities: sport events, networking events, parties, board game evenings,...