- Act as SME for Compliance, Excellence and Regulatory requirements in NPI projects and Quality, specifically with regarding to FDA Quality System Regulations and EU MDR requirements.
- Support QA and design teams in NPI and New Technology Introduction projects and product design reviews.
- Work closely with R&D and Process engineers on product risk management files amd post launch risk assessment reviews.
- Conduct root cause analysis and corrective actions, ensuring quality standards and specifications meet regulatory requirements.
- Conduct audits internally and externally, ensuring both internal manufacturing and external suppliers have quality standards aligned.
- Provide rapid resolution support for product complaint or regulatory issues.
- Work cross functionally with R&D, operations and customers in NPD, NPI and product optimization activities.
- Provide statistical analysis of verification and validation testing.
- Review and provide complete adherence for design history files and technical files, supporting the regulatory department in reviewing technical submissions.
- A level 8 engineering degree in quality assurance or similar with 5 years or more in a medical device environment
- Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
- Working knowledge of 21 CFR 820, ISO13485, MDD and MDR.
- Preferable candidate will have ISO13485, ISO14971 and QMS regulation experience.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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