Regulatory Affairs Officer (Post-Market Surveillance)

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 (POST-MARKET SURVEILLANCE)

AliveDx are recruiting a Regulatory Affairs Officer to join the Regulatory Affairs team based near Edinburgh (EH26 0BF).  The purpose of the role is building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.  In addition, the role will ensure that vigilance reporting obligations are met and will maintainthe vigilance processes. The role is a full-time, permanent position working 37.5 hours per week.

YOUR MISSION

Your main responsibilities will include:

• Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate. Ensure ongoing maintenance of these regulatory documents. 

• Advise AliveDx staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

• Develop product labelling regulatory requirements for AliveDx products and for customer contracted products including but not limited to package labels, product labels and instructions for use. 

• Product Life Cycle Management.

• Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information. 

• 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.

• Previous post market regulatory surveillance experience (BPDR submission, NDR submission and FSCA)

• Experience of working within an FDA licensed manufacturing facility.

• Knowledge and practical experience of CE and FDA regulations, including the preparation of PMA, BLA and/or 510k submissions.

• Experienced in meeting with, making presentations to, and negotiating with regulators.

• Ability to prepare coherent regulatory reports and filings.

• Great attention to detail, communication and collaboration skills.

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 and a range of core and flexible benefits ranging from pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.