Senior Regulatory Affairs Specialist
Location: NetherlandsSIRE® 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 Flevoland Netherlands.
- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries
- Several experience in Regulatory Affairs and Medical Devices
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on product launch timelines.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
The Company
International Medical Devices Company with over 300 products for among others cardiology and orthopedics.Role Description
The Senior Regulatory Affairs Specialist is responsible for preparing global regulatory submissions and communicating regulatory strategies to product development teams. Responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures.Responsibilities
- Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations.- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries
Requirements
- A Bachelor’s degree; B.S. preferred in engineering, life sciences, or equivalent technical field.- Several experience in Regulatory Affairs and Medical Devices
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on product launch timelines.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
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Job Description
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 Flevoland Netherlands.
- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries
- Several experience in Regulatory Affairs and Medical Devices
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on product launch timelines.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
The Company
International Medical Devices Company with over 300 products for among others cardiology and orthopedics.Role Description
The Senior Regulatory Affairs Specialist is responsible for preparing global regulatory submissions and communicating regulatory strategies to product development teams. Responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures.Responsibilities
- Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations.- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries
Requirements
- A Bachelor’s degree; B.S. preferred in engineering, life sciences, or equivalent technical field.- Several experience in Regulatory Affairs and Medical Devices
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on product launch timelines.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
Additional Information
- Last updated
- Employment type
- Full time
- Contract type
- Self employed
- Number of vacancies
- 1
- Min. experience
- Two years
- Min. education
- Bachelor
- Industry / category
- Jobs in Research and Development (R&D)
