Regulatory Affairs Manager

Job Description

The Regulatory Affairs role will be responsible for supporting the development of the regulatory strategy and processes for our products and services globally at Inotec AMD, working closely with cross-functional teams. The incumbent will serve as subject matter expert for assigned projects with internal as well as external stakeholders, to ensure adherence to relevant regulatory requirements.

This role reports to the COO, forms part of his leadership team and is based at the Cambridge Research Park.

Key Responsibilities

  • Responsible for worldwide country registrations, licences, establishment registrations, and renewals.
  • Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions, responses to questions, audits and inspections.
  • Responsible for Technical File/STED maintenance and updates, contributing to technical files, DHFs and tracking databases.
  • Responsible to support key R&D and clinical activities and their regulatory documentation (e.g. CER, PMS, PMCF, Risk Management, DHF, etc.) during development, post-approval and life-cycle management for medical device products.
  • Ensure that the company and company’s products comply with the regulations of the regions where they want to distribute them
  • Responsible to monitor regulatory news, legislation, guidance and practices to evaluate, alongside with other stakeholders, the impact to company and products, and any actions required.
  • Support QA/RA liaison with Health Authorities (HA) and/or notified bodies.
  • Support the development of procedures, SOPs and other controlled documents, including for Regulatory Affairs activities.
  • Support internal and external audits by regulatory agencies as required.
  • Review instructions for use, final product labelling, advertising and promotional material.
  • Provide guidance on changes, impact assessment and required updates to regulatory authorities.
  • Provide regulatory guidance and support to new product development teams.

Skills and experience required

  • BSc in Science or Engineering preferred
  • Demonstrable experience in Regulatory Affairs within the Medical Device industry, and working knowledge with CE Mark, FDA, ISO 13485, MDSAP, and International requirements
  • Experience and knowledge in preparation of regulatory documentation. Additional relevant experience with clinical trials submission and related activities would be considered
  • Collaborative and proactively communicates and initiates/executes tasks
  • Strong verbal and written communication
  • Experience in meeting tight deadlines, prioritising tasks and multi-tasking to deliver results with attention to detail
  • Ability to solves challenges and propose solutions and build cross-functional relationships internally and externally
  • IT skills, particularly in relation to using databases and familiarity with commercial software
  • Teamworking skills and the ability to lead and motivate others, and the confidence to report to management with integrity and a professional approach to work