Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs).
- Provide regulatory direction to development project teams as a core team member.
- Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions.
- Review proposed labelling for compliance with applicable global regulations.
- Review proposed product changes for impact on regulatory status of the products.
- Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides.
- Review and evaluate promotion and advertising material for compliance with applicable regulations.
- Communicate with regulatory and governmental agencies.
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
- Support additional regulatory compliance items as required by regulations and as needed by the RA team.
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
Requirements:
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
- (Preferred) Minimum of 2 years of experience in orthopaedic or medical device industry.
- (Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
- Combination of education and experience may be considered.
- Strong writing, communication, and interpersonal skills.
- Strong attention to detail.
- Able to multi-task and balance competing priorities, and willingness to work with changing priorities.
- Knowledge of overall business environment, ideally within the orthopedic industry.
- Eager to build relationships between Regulatory Affairs and other teams within the organization.
- Ability to communicate effectively at all levels.
- Advanced knowledge of FDA, EU, and other regulatory body regulations.