Senior Regulatory Affairs Manager | 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 Senior Regulatory Manager is part of the Regulatory Affairs Team. In this position the Senior Manager will be responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care. The Senior Regulatory manager is a strategic partner for the business groups. The activities will focus on a hair removal devices.

Senior Manager with strong commercial business sense, who has consumer safety and product compliance top of mind. Able to work in a high pressure, result driven, project environment. Strong communicator and collaborator and team player. Excellent English language skills in writing and speech. HBO or University level of thinking.

Responsibilities

- Take “Regulatory Ownership” of the Medical Devices, being the primary point of contact for the development teams.
- Involved early in Advanced Development Projects and Value Proposition Creation
- Involved in Clinical Claim Development
- Create Assessments of Medical Device Classifications for applicable Markets globally
- Create Regulatory Strategy Plan for new Hair Reduction device projects
- Review Product Compliance Plans as created by Safety & Compliance Managers
- Create Product Labeling Plan
- Review Clinical Study Plan and Reports
- Create Regulatory Medical Device Submission Packages for markets like EU, U.S., Brazil, China.

Requirements

- 10-15 year experience in medical device regulations, in a commercial environment
- Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa)
- Proven successful track record in regulatory submissions for medical devices
- Knowledge of Clinical Study setup, execution and reporting
- Familiar with MDSAP and ISO 13485
- Knowledgeable on Product Risk Assessment strategies
- Strong Senior Personality being able to take position and guide a project team

Other information

Nice to have:
- Knowledge of different standards for household and medical devices (e.g. electrical standards)
- Knowledge on Software Development
- Pharmaceutical background

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.