What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Determine appropriate regulatory requirements and filing strategies for the release of new and/or modified medical devices and pharmaceutical products
- Prepare and submit regulatory submissions (e.g., 510(k), NDA supplements, Medical Device License Applications) and internal documentation for medical devices to health authorities in the Americas, including FDA, Health Canada, and Lat Am regulators
- Direct interaction with FDA during submission review process
- Active team member during product development to provide guidance on regulatory requirements
- Assist in handling routine responses to data and information requests from regulatory agencies and internal departments
- Assist in the development and review of product labelling and promotional materials for compliance with medical device regulations
- Serve as strategic regulatory partner to the commercial team both pre and post approval activities
- Bachelor's degree in science (biology, chemistry, microbiology, etc.), engineering, or medical field preferred.
- 5 years' experience in Regulatory Affairs role with medical devices and/or pharmaceuticals; experience in direct interaction with US FDA required.
- Working knowledge of the healthcare industry, quality systems, promotional compliance, and governing regulations.
- Strong communication skills (written and verbal) necessary in order to regularly interact with internal contacts, regulatory agencies, researchers, and customers.
- Critical and analytical thinking.
- Strong organizational skills and attention to detail.
- Basic computer skills, including Microsoft Office Suite
