Regulatory Affairs Specialist | Medical Devices

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.

The Company

The company is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. They leverage advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

Role Description

The Regulatory Affairs Specialist (RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The specialist also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. The RA Specialist cooperates closely with Product Development, Medical Affairs and Marketing and Sales as part of a new product introduction or maintenance project. Often multiple smaller projects at the same time.

Responsibilities

- Responsible for developing and implementing global regulatory strategy and road maps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
- Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada].
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Communicate application progress to internal stakeholders
- Maintain regulatory files and tracking databases as required
- Communicate with regulatory agencies as needed
- Collaborate with worldwide colleagues regarding license renewals and updates as needed (yet normally done by RA international team)
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

Requirements

- Minimum of 2 years of experience in medical device regulated environment.
- Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
- Available in short time
- Enthusiastic, self-motivated regulatory professional
- Structured way of working
- Problem solving and time management skills

Other information

Nice to have:
- Real knowledge on Medical Devices Regulations (MDR)
- Working knowledge of Medical Device Regulations other than FDA/MDD
- Knowledge on standards
- Regulatory Affairs Certification

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