Regulatory Affairs Officer

Alba Bioscience Limited

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba-- our blood bank reagents portfolio-- and MosaiQ®-- one of the first multiplexing and multimodality automated testing platforms--are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

Regulatory Affairs Officer

AliveDx is recruiting for a Regulatory Affairs Officer to join the Regulatory Affairs & Quality team based in Penicuik, Scotland.

The role is a full permanent position working flexible working hours.

YOUR MISSION
The Regulatory Affairs Officer is responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide.

**Your main responsibilities will include**:
Prepare, write and compile regulatory documentation, coordinate and execute regulatory submission with FDA, European Notified Bodies, Health Canada and any other territories as appropriate;
Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met;

Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) - Part 1 and other non-registered product requirements to support compliance for Quotient and its products;
Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information;
Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.

Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities;
Assist with the implementation of the Company’s Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

YOUR COMPETENCIES
A relevant degree and/or relevant work experience in a regulatory affairs environment;
Ability to prepare coherent regulatory reports and filings;
Sound knowledge and expertise with core IT packages i.e. MS Office;
Clear spoken and written communication;
Effective external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers;
Proactive and able to work effectively independently or within a team, participating in R&D project teams as required and deliver end results under tight timelines;
Great attention to detail with a thorough and methodical approach to work. Ability to analyse information in a structured manner;
Ability to work under pressure of a high workload, meet deadlines and respond flexibly;
Effective time management and prioritisation skills;
High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same;
Adequate leadership skills in order to be able to take on a supervisory role when required/appropriate;
Good business acumen;
WHAT WE OFFER
A highly dynamic and growing environment.
An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
A flexible working environment where applicable as well as a range of core additional benefits ranging from lunch allowance support, annual leave, mobility and access to marketplace discounts.