International Regulatory Affairs Specialist
Katalyst Healthcares & Life Sciences Baltimore, MD
- Expired: over a month ago. Applications are no longer accepted.
- Prepare international submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with engineering partners, Geography Regulatory partners, and regulatory agencies as needed.
- Prepare regulatory strategies/plans and compliance requirements.
- Provide on-going support to project teams for regulatory issues and questions.
- Find, interpret, and apply regulations and guidance appropriately for situations.
- Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
- Provide regulatory support for currently marketed products. This includes reviewing labeling and changes to existing devices and documentation.
- Prepare submissions and reports for regulatory agencies as required.
- Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.
- Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, requirements on testing, etc.
- Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc.
- Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Work under general supervision following established procedures. Independently determines and develops approach.
- Frequent inter-organizational contact and some external contacts.
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
- Provide training and support to other members of the department.
- Other tasks, as required.
- Bachelor's degree with a minimum 2 years of experience in regulatory affairs, medical device.
- Or advanced degree with 0 years of experience in regulatory affairs, medical device, or quality.
- Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
- 4+ years medical device industry experience
- In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Experience with Class III medical devices (PMA)
- History of successful device submissions
- Strong negotiation skills and written/oral communication skills.
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines.
- Ability to work independently and under general direction only.
- Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
Katalyst Healthcares & Life Sciences
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