Overview

Job Title:Quality & Regulatory Affairs Specialist

Job Type:Permanent position

Location:Outskirts of Edinburgh (Hybrid, 3x a week in the office)

Remuneration:Up to £50,000 + Benefits

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. Reporting to the Chief Regulatory Affairs and Quality Officer, the Quality & Regulatory Affairs Specialist is 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. The role is also responsible for supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.

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 for AliveDx Suisse SA

· 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.)

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