Austin Vita has a fantastic opportunity for a Regulatory Affairs Specialist to join a well reputed Medical Device Consultancy where you can expect to work on a wide range of interesting and challenging projects. The position can be fully remote and will suit someone with MDR and FDA Regs works experience.
You will leverage your extensive medical device industry/consulting experience to provide expert level regulatory consulting services:
- Develop effective product registration strategies for customers (product classification and solutions for bringing product to the market)
- Use medical device background knowledge to perform critical review and gap analysis of product documentation and regulatory submissions
- Prepare high-quality premarket submissions, e.g., FDA 510(k) / de novo, Canadian MDLs, EU Technical Documentation Files, and other global registrations
- Request and support Pre-Submission meetings and liaise with government authorities on behalf of clients.
- Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
- Provide SME guidance in all aspects of global Medical Device and In Vitro Diagnostic (IVD) regulations
- Develop Clinical Evaluation / Performance Evaluation Plans & Reports
- Support with strategy and submissions for novel devices/technology: FDA Breakthrough Device Designation / de novo submissions; Health Canada guidance communications; other international markets as needed.
- Specialised support in areas such as; SaMD, cybersecurity, risk management, sterilisation, etc.
- Use industry experience to guide and assist manufacturers with meeting Post-Market requirements, e.g., change management and promotional compliance
What makes you a great fit:
- Bachelor's degree or equivalent in a scientific discipline, particularly biomedical engineering, quality engineering, microbiology or chemistry
- ≥8 years of Regulatory Affairs and Quality Assurance Medical Device industry experience, ideally at a Team Leader/Managerial / Director level
- A demonstrated knowledge and understanding of global medical device regulations, especially MDSAP countries and the EU / UK
- RAC, CQE, CQA or other quality certification preferred
- Auditing experience to medical device standards (QSR, ISO 13485, MDSAP), a Lead Auditor Certification is an advantage
- Experience with writing and compiling technical documentation
- Client-facing experience and strong interpersonal skills with the ability to work with C level executives of a client's organisation
- Fluency in Business-level English
You will be rewarded with a fantastic salary and benefits including; 15% bonus per annum, Life insurance, private medical, pension, 25 days holiday, and enjoy flexibility of remote working.
If this sounds of interest to you, please apply ASAP.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.