Regulatory Affairs Professional
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!
Our client is a professional Medical Devices and Pharmaceutical organization, based in Noord-Holland Netherlands.
Global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives
This is a key staff position which has responsibility for Regulatory Affairs for the company. Will establish and maintain compliance to applicable regulatory requirements will prepare and manage submissions and technical files. Will also hold responsibilities for the Quality Assurance activities, as assigned. May also be assigned to certain Advanced QRA activities.
- Responsible for Regulatory Affairs including but not limited to regulatory strategies, submissions, technical files, and approval of labelling, advertising and promotional materials.
- Responsible for Regulatory Affairs on behalf of product development projects (including claims extension projects) and to meet regulatory requirements.
- Work collaboratively with members of global regulatory team to coordinate the development of regulatory strategies to meet business needs. As assigned, manage or support the creation and submission of international filings.
- Will also be responsible for Quality Assurance and compliance activities as determined by management.
- Serve as a contact with the US FDA and other government officials while representing for submission reviews, face-to-face meetings, teleconferences and written communications.
- Maintain accurate and complete regulatory files and applicable records.
- Use Business System tools to establish and improve processes.
- Bachelor’s degree in science, medical or technical field and 5+ years experience with increasing responsibility in medical device Regulatory Affairs, or
Graduate degree in science, medical or technical field and 5+ years experience with increasing responsibility in medical device Regulatory Affairs.
- Experience in the medical device field, IVD preferred
- Must have requisite training or certification in medical device regulatory affairs through on-the-job training, seminars, training. RAC certification preferred.
- Knowledge of medical device regulations in EU, USA and other markets such as Japan, China and Brazil.
- Demonstrated success performing a wide range of regulatory affairs activities including submissions, technical files, risk assessments, approval of labeling, advertising and promotion.
- Strong organizational and analytical thinking skills. Ability to multitask.
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.
- Exceptional communication skills (verbal/written/presentation/relationship building)
- High level of initiative, self-motivation and energy.
- High level of integrity
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.