Regulatory Assistant
About ANGLE:
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system. ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.
Join our Team:
This is an exciting time at ANGLE and our team in Guildford are looking for a competent and motivated Regulatory Assistant with a focus on In Vitro Diagnostics (IVD) devices within the dynamic and rapidly evolving field of liquid biopsy. The ideal candidate will have worked in a regulated environment within the field of medical devices, IVDs or pharmaceuticals. This fantastic position offers a unique opportunity to contribute to the design, development and regulatory registration of the state-of-the-art technologies.
At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.
We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.
Principal Accountabilities:
- Preparation of regulatory submissions for global market clearance.
- Support product clearance through US FDA, EU (IVDR) and other global regulatory markets.
- Participate in Design Control, Risk Management, Post Market Surveillance and change control procedures.
- Assist in the production, review and maintenance of product technical files adhering to global regulations and standards.
- Update and review product IFUs, packaging and promotional labelling.
- Assist in providing the business with up-to-date regulatory intelligence.
- Work in close liaison with the Quality department for the ISO 13485 QMS and FDA 21CFR part 820 QSR maintenance, and ISO 15189 accreditation of ANGLE’s Clinical laboratory.
- Assist in internal and external audits.
- Other duties as required by Regulatory Affairs department.
- Undertake additional ad-hoc tasks as required.
Qualifications, Experience, Knowledge and Attributes:
- Degree in Science or Engineering.
- Minimum 2 years of Regulatory experience within a medical device or pharmaceutical environment is highly desirable.
- RAC preferred.
- Experience of ISO 13485, FDA 21CFR medical device and IVD codes.
- Experience dealing with Notified Bodies and global regulatory authorities is preferred.
- Attention to detail, excellent document management and organising skills.
- Effective communicator.
- An eye for detail and commitment to high quality data.
- A flexible, can-do approach to the requirements of the job.
Job Requirements:
- Due to the nature of the role, our requirement for this position is to be full-time, Guildford based, with flexibility to work from home at the discretion of the Manager. Minimum requirement to travel to the Guildford office is 3 days every week.
As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package.
Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.
Furthermore, please be advised that if you submit an application to us for this position, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.
Important notice to Employment Businesses/ Agencies:
ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.