Senior Regulatory Compliance Officer - IVDs

Job Title: Senior Regulatory Compliance Officer - IVDs

Job Type: 12 month fixed term contract

Location: Outskirts of Edinburgh (Hybrid)

Remuneration: £35,000 - £40,000

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role you will be responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting.

The role is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.

Responsibilities:

·       Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.

·       Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

·       Ensure Quality Assurance release of incoming goods, intermediate and final product obligations.

·       Ensure Supplier management obligations.

·       Ensure Post-market surveillance obligations.

·       Ensure Vigilance reporting obligations.

·       Be a point of contact for regulatory & quality compliance issues.

·       Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).

·       Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.

·       Support QMS organization during regulatory inspections or certifications audits.

·       Perform any other duties as reasonably requested from the Company from time to time.

·       Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.

Requirements:             

·       Master degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.

·       Level required in the function (e.g.: validation, finance, quality control)

·       Experience in medical device / IVD / biotech industry

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

·       Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills)

·       Significant 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, CMDR, etc..).

·       Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.)

For more information please reach out to please note that you MUST have the full right to work in the UK and be able to be office based 3x a week.