Regulatory Affairs Specialist

Employment Type
Not disclosed
Tcoag logo

Job Title

RA Specialist

Reports to

QA/RA Product Manager

Purpose of job

Review and comply with international requirements on regulations that affect the business. Gain strong understanding of labelling claims to ensure registration files are adequate. Maintain Tcoag reagents and instruments global registrations listing. Maintain registrations through annual reports and updates of changes. Actively participate in assay development and instrumentation projects to help maintain regulatory compliance.

Essential responsibilities

  • Gain strong understanding of worldwide regulatory requirements as they affect our products.
  • Comply with internal procedures to ensure continuous compliance with all regulatory requirements. 
  • Obtain the necessary information in support of product registrations and communicate with external Customers & Regulatory Agencies during the registration process.
    • Support activities arising from routine process and design change activities.
    • Provide advice and training as needed to internal processes and customers on reagent and instrument changes and design projects.
    • Maintain Technical files, Design History Files, according to internal and external requirements.
      • Support the vigilance system and the day-to-day activities of Complaints Review Team.
      • Maintain contacts with external organisations to be aware of developing trends and inform internal organisation on impact. 
      • Gain strong understanding of requirements on product labelling and warnings needed
      • Know when to escalate issues to senior management and corporate staff.
      • Use the highest level of integrity in assessing regulatory criteria and documentation.
      • Be prepared to cross-train in other QA/RA functions to provide backup.
    • Qualifications

      • Degree or equivalent industrial experience
      • At least 2 years’ regulatory experience in the Medical Device industry, preferably in IVDs
      • Familiarity with regulatory requirements of IVD Directive 98/79/EC and equivalent FDA and Health Canada requirements
    • Skills and Behaviours 

      • Ability to analyse and interpret regulatory texts.
      • Will pay attention to detail and work with a sense of urgency. 
      • Must have excellent written and verbal English skills.
      • Team player – ready, willing and able to take direction and receive constructive feedback 
      • Will have a willingness and ability to collaborate with and influence others in a positive, team‑based environment. 
      • Self-motivation with strong work ethic and organizational skills and ability to prioritize, schedule and plan ahead
      • Ability and willingness to engage with Stago systems and personnel
    • Language Skills

      Fluent English both written and oral.

      The above requirements are not exhaustive and are provided to show the most common tasks and may be amended or updated as required.