Regulatory Compliance 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 COMPLIANCE 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 for implementing and maintaining regulatory compliance processes including regulatory evaluation of non-conformances, post market surveillance, vigilance and associated reporting, regulatory and standard watch.  The role is responsible for coordinating the HHE activities that may be required based on individual non-conformances or product complaints.

YOUR MISSION

Your main responsibilities will include:

• Be the main contact for regulatory compliance issues

• Provide PMS documentation according to IVDR requirements (PMS Plan, SSP, PMS Report, PSUR)

• Lead and coordinate the vigilance process in interface with the complaint handling process

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

• Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports)

• Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards.

YOUR COMPETENCIES

• A relevant degree and/or relevant work experience in a regulatory affairs environment.

• Experience in medical device/IVD/Biotech industry

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

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

• Specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc..).

• 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.