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Senior Consultant & Technical Specialist – Medical Devices
| Posting date: | 07 February 2025 |
|---|---|
| Salary: | £65,000.00 per year, pro rata |
| Hours: | Full time |
| Closing date: | 17 February 2025 |
| Location: | UK |
| Remote working: | Fully remote |
| Company: | Sterile Management Systems Ltd |
| Job type: | Permanent |
| Job reference: |
Summary
We are a small but growing boutique consultancy supporting the medical devices industry, with a particular focus on sterile and/or non-active devices. We are looking for an experienced Senior Consultant & Technical Specialist to join our team.
In this role, you will support our clients in developing technical documentation to meet global medical device regulations, including but not limited to the UK, EU, USA, Canada, Australia, Brazil, Japan and ASEAN.
Our clients are predominantly UK-based but steadily expanding. We work with a range of companies, from SMEs to multinationals, start-ups to well-established technology providers.
This is a home-based role, with all necessary IT equipment provided. Occasional travel may be required (up to 10%), primarily within the UK, though some international travel may be possible.
________________________________________
Essential Skills & Experience:
✔ Regulatory expertise – experience in medical devices regulatory management and/or working with regulatory authorities (e.g., Notified Body, MHRA), 7 years minimum
✔ Broad device experience – active/non-active, non-invasive/invasive/implantable, clinical use…etc.
✔ Design & development – experience with design planning, verification, and validation
✔ Specialist technical expertise – preferably in biocompatibility, clinical evaluation and/or sterilisation, however we are also keen to hear from applicants with expertise in any of the following areas: IVD performance evaluation, clinical investigation & PMCF, control of human or animal tissues, drug-device combinations, electrical safety and EMC testing, software lifecycle development, verification and validation (including AI), human factors / usability engineering.
________________________________________
Desirable Skills & Experience:
➕ Borderline product regulation – experience with biocides, PPE, pharmaceuticals, or cosmetics
➕ Manufacturing process engineering / validation
➕ ISO13485 quality management system implementation or auditing
➕ Experience in delivering specialist training (remote and face-to-face)
________________________________________
Additional Information:
Open to applicants from the UK & Ireland
Competitive salary – starting from £65k+, dependent on experience
⏰ Flexible working patterns considered – e.g., flexitime and/or part-time
Friendly team, “No big company politics”!
If you have any questions, feel free to reach out. Otherwise, we look forward to receiving your CV along with a brief covering letter/message explaining why you'd like to be considered for this role.
No recruitment agencies, please!
In this role, you will support our clients in developing technical documentation to meet global medical device regulations, including but not limited to the UK, EU, USA, Canada, Australia, Brazil, Japan and ASEAN.
Our clients are predominantly UK-based but steadily expanding. We work with a range of companies, from SMEs to multinationals, start-ups to well-established technology providers.
This is a home-based role, with all necessary IT equipment provided. Occasional travel may be required (up to 10%), primarily within the UK, though some international travel may be possible.
________________________________________
Essential Skills & Experience:
✔ Regulatory expertise – experience in medical devices regulatory management and/or working with regulatory authorities (e.g., Notified Body, MHRA), 7 years minimum
✔ Broad device experience – active/non-active, non-invasive/invasive/implantable, clinical use…etc.
✔ Design & development – experience with design planning, verification, and validation
✔ Specialist technical expertise – preferably in biocompatibility, clinical evaluation and/or sterilisation, however we are also keen to hear from applicants with expertise in any of the following areas: IVD performance evaluation, clinical investigation & PMCF, control of human or animal tissues, drug-device combinations, electrical safety and EMC testing, software lifecycle development, verification and validation (including AI), human factors / usability engineering.
________________________________________
Desirable Skills & Experience:
➕ Borderline product regulation – experience with biocides, PPE, pharmaceuticals, or cosmetics
➕ Manufacturing process engineering / validation
➕ ISO13485 quality management system implementation or auditing
➕ Experience in delivering specialist training (remote and face-to-face)
________________________________________
Additional Information:
Open to applicants from the UK & Ireland
Competitive salary – starting from £65k+, dependent on experience
⏰ Flexible working patterns considered – e.g., flexitime and/or part-time
Friendly team, “No big company politics”!
If you have any questions, feel free to reach out. Otherwise, we look forward to receiving your CV along with a brief covering letter/message explaining why you'd like to be considered for this role.
No recruitment agencies, please!