Regulatory Affairs Specialist
Application Deadline:
21 January 2025 Department:
Q & RA Employment Type:
Full Time Location:
Oxford Reporting To:
Quality & Regulatory Director
Description
Want to be part of a team transforming healthcare?
We are looking for an experienced
Regulatory Affairs Specialist
to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Working within the Quality and Regulatory team, you will be responsible for ensuring compliance with applicable regulations, guidance, and standards for jurisdictions where Adaptix radiation emitting Class II (FDA) and Class IIb (CE) medical devices, veterinary and non-destructive testing devices are marketed.
The Company
Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much more expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile, low dose systems that can be brought to patients and deliver imaging at point-of-care.
Candidate Profile
As our ideal candidate, you have a degree in Science or Engineering, along with a recognised regulatory qualification (e.g. Regulatory Affairs Certification) or equivalent experience. Key Responsibilities
Main duties and responsibilities:
Working with colleagues in the Quality & Regulatory team, and leading on regulatory submissions (e.g. UKCA, CE under MDR, 510k), preparing responses to queries from regulatory authorities, and managing registrations and listings globally for all Adaptix product families. Writing, analysing and editing technical documents to support country-specific regulatory submissions and compiling submissions in a format consistent with applicable guidance documents. Working collaboratively across the organisation to manage and communicate the requirements for regulatory submissions. Assessing and documenting the regulatory impact of product design changes in jurisdictions where the product is licensed. This can include mechanical, electrical and software design, and security features. Conducting post-market surveillance activities and communication with regulatory authorities. Providing additional support to the Quality & Regulatory team, for example by participating in design projects as an independent reviewer.
Skills, Knowledge and Expertise
Skills:
In-depth knowledge of the EU and US regulatory landscapes of, X-ray medical (essential), veterinary and non-destructive testing devices (desirable) Knowledge of design and development process principles according to ISO 13485:2016 (essential) and 21CFR820 quality system regulations (desirable) Excellent technical writing skills and ability to handle large documentation sets for regulatory submissions Understanding of medical device security and cybersecurity requirements in the EU and USA Working knowledge of UDI labelling requirements and process Excellent organisational and planning skills with ability to manage concurrent projects and adapt to changing priorities Gains the trust of others by providing expert information and advice in a professional and credible manner and inspires others to do the same Detail focus with the tenacity to see tasks through to their successful completion Ability to communicate technical requirements both verbally and in writing, and build positive internal and external relationships Proactive, self-motivated and driven to achieve results Comfortable working both independently and collaboratively within a team Experience:
Proven track record of managing registrations with FDA, MHRA, or European competent authorities Experience in hosting / assisting in NB / Regulatory authorities audits Active involvement in post market surveillance processes in higher class devices across multiple territories Managing contracts with CE Authorised representatives Medical X-ray FDA and CE regulatory submissions (desirable) FDA's Third party review process (desirable) Compilation of technical documentation for non-medical devices in EU and USA (desirable) Apply Now
This is a permanent full-time role based at our commercial offices in Oxfordshire. Compensation is competitive and commensurate with experience.
Please note the closing date, however should we find a suitable candidate before this date, the position may be filled earlier. Please note that we are unable to provide sponsorship for visa applications for this role.
If you feel that you would excel in this role we would be delighted to hear from you! #J-18808-Ljbffr
Application Deadline:
21 January 2025 Department:
Q & RA Employment Type:
Full Time Location:
Oxford Reporting To:
Quality & Regulatory Director
Description
Want to be part of a team transforming healthcare?
We are looking for an experienced
Regulatory Affairs Specialist
to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Working within the Quality and Regulatory team, you will be responsible for ensuring compliance with applicable regulations, guidance, and standards for jurisdictions where Adaptix radiation emitting Class II (FDA) and Class IIb (CE) medical devices, veterinary and non-destructive testing devices are marketed.
The Company
Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much more expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile, low dose systems that can be brought to patients and deliver imaging at point-of-care.
Candidate Profile
As our ideal candidate, you have a degree in Science or Engineering, along with a recognised regulatory qualification (e.g. Regulatory Affairs Certification) or equivalent experience. Key Responsibilities
Main duties and responsibilities:
Working with colleagues in the Quality & Regulatory team, and leading on regulatory submissions (e.g. UKCA, CE under MDR, 510k), preparing responses to queries from regulatory authorities, and managing registrations and listings globally for all Adaptix product families. Writing, analysing and editing technical documents to support country-specific regulatory submissions and compiling submissions in a format consistent with applicable guidance documents. Working collaboratively across the organisation to manage and communicate the requirements for regulatory submissions. Assessing and documenting the regulatory impact of product design changes in jurisdictions where the product is licensed. This can include mechanical, electrical and software design, and security features. Conducting post-market surveillance activities and communication with regulatory authorities. Providing additional support to the Quality & Regulatory team, for example by participating in design projects as an independent reviewer.
Skills, Knowledge and Expertise
Skills:
In-depth knowledge of the EU and US regulatory landscapes of, X-ray medical (essential), veterinary and non-destructive testing devices (desirable) Knowledge of design and development process principles according to ISO 13485:2016 (essential) and 21CFR820 quality system regulations (desirable) Excellent technical writing skills and ability to handle large documentation sets for regulatory submissions Understanding of medical device security and cybersecurity requirements in the EU and USA Working knowledge of UDI labelling requirements and process Excellent organisational and planning skills with ability to manage concurrent projects and adapt to changing priorities Gains the trust of others by providing expert information and advice in a professional and credible manner and inspires others to do the same Detail focus with the tenacity to see tasks through to their successful completion Ability to communicate technical requirements both verbally and in writing, and build positive internal and external relationships Proactive, self-motivated and driven to achieve results Comfortable working both independently and collaboratively within a team Experience:
Proven track record of managing registrations with FDA, MHRA, or European competent authorities Experience in hosting / assisting in NB / Regulatory authorities audits Active involvement in post market surveillance processes in higher class devices across multiple territories Managing contracts with CE Authorised representatives Medical X-ray FDA and CE regulatory submissions (desirable) FDA's Third party review process (desirable) Compilation of technical documentation for non-medical devices in EU and USA (desirable) Apply Now
This is a permanent full-time role based at our commercial offices in Oxfordshire. Compensation is competitive and commensurate with experience.
Please note the closing date, however should we find a suitable candidate before this date, the position may be filled earlier. Please note that we are unable to provide sponsorship for visa applications for this role.
If you feel that you would excel in this role we would be delighted to hear from you! #J-18808-Ljbffr
