As an experienced Regulatory Affairs Manager within a Class II Medical Device design and manufacturing environment, you will be well equipped to take on this superb opportunity in the Netherlands. You will be responsible for leading the regulation process for all Company medical devices, from the development of regulatory strategies, preparing and filing the necessary applications and handling all governmental/ regulatory agency interactions through to approval. You will be part of the Senior Leadership Team with 2 direct reports.
- Devising regulatory strategies to ensure rapid and timely approval of Company life changing medical devices.
- Interpreting existing or new regulatory requirements as they relate to Company products and procedures, clinical studies, testing, or records keeping.
- Providing regulatory guidance and support to project teams including regulatory filing strategies, testing and standards requirements and support RA staff in filing process.
- Reviewing, analysing and approving technical data generated by Research and Development, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes.
- Reviewing, providing feedback and approving design and manufacturing changes, nonconforming materials reports, rework orders, test protocols and reports to ensure regulatory compliance with applicable standards, and determine filing requirements.
- Reviewing promotional and advertising materials, complaints and lead vigilance and MDR reporting efforts.
- Preparing US and International regulatory submissions, including, but not limited to IDE/IDE Supplements, CE, 510Ks, PMAs/ Supplements, Annual Reports, Technical Files, and Design Dossiers and Change Notices
- Reviewing and advising on labelling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations.
- Advising on international product registration and export approval requirements.
- A proven track record in Regulatory Affairs, preparing submissions for Class II medical devices in the US, EU and internationally for successful approval.
- A Bachelor's degree in Engineering, Life Science or equivalent.
- Must have extensive experience in the preparation, and submission of Pre-IDEs, IDEs, PMA supplements, Technical Files, Dossiers and amendments and a successful track record.
- Must be able to work independently and multitask in a time-line driven late stage start-up/ early commercial environment.
- Must have excellent verbal and written communication, presentation skills, including experience presenting at FDA meetings.
- Must be able to communicate clearly, succinctly and effectively over the phone and in writing with various stakeholders including Regulatory Agencies.
- Skilled in leading and mentoring staff through influence rather than position power to achieve significant results
- Strong verbal and written communication skills in English. Dutch language is not required
- Company Pension
- The Netherlands enables some tax relief benefits
- Lovely working environment
- Future possibilities available for the right person
8.30-5 Mon-Fri To apply, or to find out more information, please click on one of the "apply" buttons
Please note that due to a high level of applications, we can only respond immediately to applicants whose skills & qualifications are suitable for this position.
Meridian Business Support is acting on behalf of our Client as a Recruitment Business.