The main purpose of this role would be to act as subject matter expert on relevant standards and regulations related to the combination products line, as well as ensuring the smooth cooperation between R&D and Quality. As such, we are looking for a candidate with strong communication skills who can effectively mediate, whilst providing sound technical knowledge.
- Provide expert knowledge on FDA, ISO and MRD standards and ensure that all products within the Combination Products line meet such standards - from the design stage, all the way to post market
- Work closely with internal and external teams and authorities to ensure standards are being adhered to and manage escalations in accordance to relevant procedures and policies
- Keep updated on new regulatory standards and integrate new practises according to new rules and principals
- Aside from enforcing correct Design Control Processes, this role will be responsible for providing continued and quality progress reports, risk analysis, statistical data analysis etc. and participate in periodic audits
- University degree level in Mechanical / Biomedical engineering, life sciences or related
- At least 5 years of experience working in a similar role, either quality, engineering or manufacturing for medical devices or combination products
- A strong understanding of Design Control Processes /Quality Design Controls is a must, as well as ISO, FDA and MDR standards (Specifically 21 CFR part 4 / 11)
- Strong Communication skills in order to negotiate, mediate and effectively push adherence to standards and regulations
- Fluency in English, German a plus
Our client offers the chance to work for a reputable and global company, with excellent benefits and work-life balance. If you think you profile is a good fit and would like to learn more, please share with me your CV at email@example.com
Look forward to hear from you!