About this role
The Senior Quality & Regulatory Affairs Consultant will work within Emergo’s consulting team, providing assistance with regulatory and quality compliance issues to clients in accordance with written Work Instructions and the signed proposal / SOW.
- Bachelors' degree in a science discipline such as biomedical engineering, Quality engineering, microbiology or chemistry
- 5 years of Quality Assurance and Regulatory Affairs industry experience, ideally at a team lead / supervisory level.
- A demonstrated knowledge and understanding of global medical device regulations, especially MDSAP countries and the EU / UK. / LatAm
- Experience with writing and compiling technical documentation.
- Experience with risk management files (ISO 14971).
- Client-facing experience and strong interpersonal skills.
- Fluency in English.
OTHER DESIRED COMPETENCY AND QUALIFICATIONS:
- Post-graduate degree.
- Lead auditing experience (QSR, ISO 13485, MDSAP).
- Clinical Evaluation report preparation.
- Experience with IVDs and/or device software / SaMD.
- Experience with presenting training to groups.
- Fluency in additional languages.