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Job Description
Regulatory Affairs Specialist sought to ensure product compliance with global regulatory standards, executing CE marking activities and coordinating with Notified Bodies.
Technopath Clinical Diagnostics, a leading innovator in in vitro diagnostics, is expanding its product offerings and entering new markets.
Job Description
As a Regulatory Affairs Specialist, you will play a crucial role in maintaining product registrations and submissions in various regions, including the US, Australia, Brazil, Canada, and Europe.
- Execute and lead CE marking activities
- Coordinate with Notified Bodies
- Ensure compliance with global regulatory standards
- Maintain product registrations and submissions in various regions
Key qualifications include:
- Proven experience in regulatory affairs within the IVD and medical device industries
- In-depth knowledge of global regulatory requirements, including FDA 510(k), TGA, ANVISA, and Health Canada
- Experience working with Notified Bodies for CE marking conformity assessments
- Ability to travel onsite 1-2 days per week
Additional requirements include:
- Good communication skills, both verbal and written
- Ability to collaborate effectively across teams
- Meticulous mentality with excellent interpersonal and prioritization skills
Minimum of degree qualification in relevant Science, Engineering, or Quality Assurance discipline required.