Regulatory Affairs Specialist
Company: Katalyst Healthcares & Life Sciences
Location: Jersey City
Posted on: January 21, 2023
Job Description:
Responsibilities
- Provide guidance in preparing country specific dossiers for
submissions worldwide.
- Generate templates for domestic (US FDA, Canada) and
international (EU, Australia, Turkey, etc) submissions.
- Communicate directly with the international affiliates and the
regulatory intelligence team.
- Update and maintain the submission templates.
- Liaison the requirements with the Product Manager and the
development team.
- Manage the internal regulatory intelligence team.
- Create internal processes and systems to ensure regulatory
intelligence provided by RegDesk is of the highest
quality.
- Review work of regulatory intelligence team.
- Contribute ideas to enhance RegDesk's RIM platform.
Requirements:
- Bachelor's Degree or equivalent experience preferred
- Minimum 5 years' experience in the Medical Device Regulatory
Affairs
- Thorough understanding of US, EU, Canada regulations on medical
devices and IVDs
- Prior experience authoring dossier content and addressing
health agency inquiries is a must
- Superior attention to detail
- Strong written and verbal communication skills
- Able to multitask effectively and work independently with
international oversight
- Knowledge of 21 CFR Part 11 requirements
Keywords: Katalyst Healthcares & Life Sciences, Jersey City , Regulatory Affairs Specialist, Other , Jersey City, New Jersey
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