AMLo Biosciences Ltd - Quality Assurance and Regulatory Affairs Manager
- Job Title:
- Quality Assurance and Regulatory Affairs Manager
- Technical roles
- Closing Date:
Hours: Full Time, 37.5h per week, Monday-Friday
Renumeration: £40-45k p.a. plus pension contribution
is an early stage biotechnology company based in the Biosphere Building on Newcastle Helix. We are developing a range of prognostic tests for oncology indications to improve patient outcomes and save healthcare resources. Our first product, AMBLor, targets the deadliest skin cancer, melanoma, identifying tumours which are at low-risk of recurrence or spread by analysis of the primary tumour biopsy. This test is currently undergoing clinical and analytical validation to allow CE marking in mid-2021. Our next two products target another skin cancer indication, cSCC and the head and neck cancer, OPSCC. Both these products are at the R&D stage.
This is an exciting opportunity for a talented Quality Assurance and Regulatory Affairs Manager to join our team on a permanent, full-time basis. The key focus for this role is the management responsibility for the development and maintenance of the company quality policy in accordance of ISO 13485 as well as responsibilities for global regulatory submissions.
You will work closely with the CEO to ensure that we are fully compliant with all policies, procedures and regulations and that all business objectives are met.
The Key Responsibilities
- Drafting the company’s regulatory documentation, as well as managing their technical files and contractors.
- Working directly with our technical team and highly experienced contractors to help bring each product through the in vitro diagnostic (IVD) regulatory pathway.
- Support for the development of the company’s regulatory plan, incorporating strategies for the product range in accordance with global requirements.
- Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business.
To be successful within this role, you will need:
- Bachelors/Masters’ degree in a scientific or engineering degree
- A minimum of 2 years' experience in QA ISO quality systems for IVDD (in-vitro diagnostics) and managing a quality system.
- Thorough understanding of regulations and compliance within healthcare diagnostics;
- Hands-on experience of implementing and managing quality assurance systems (ISO13485)
- Hands-on writing regulatory documentation, including technical files, risk assessments and design history files.
- Good knowledge of relevant ISO standards
- Experience of auditing;
- Strong attention to detail;
- Excellent communication and people skills;
- Outstanding, written English and are an exceptionally articulate person in writing;
- Significant experience in the healthcare diagnostic industry, with solid knowledge and experience in quality and compliance for IVDs;
- A self-starter who doesn’t need direct supervision to motivate you for success – we believe strongly in building a culture of individual accountability and ownership.
- Competitive salary £40-45k per annum on full time basis, depending on experience
- 25 days annual leave plus bank holidays
- Auto enrolment pension
- Employee share option scheme
- Flexible working available
- Important Info
- Location: The Biosphere, Newcastle upon Tyne
- Starting date: ASAP
- Job type: Permanent, Full-time (but a part-time working pattern would be considered)
- Visa sponsorship is not available.
We do not work with recruiters
Please submit a letter describing how you skills and experience match the job description accompanied by a current CV to firstname.lastname@example.org
. The closing date for applications is 31st January 2021. Interviews will take place week commencing 8th February 2021.