• Recognized as a key talent in US, EU, or Japan.
• Considered a key regulatory point person.
• Can be trusted by Regulatory Affairs (RA) management as an independent regulatory core team lead on project/sustaining teams
• 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
• Ability to manage conflict with and motivate teammates on project teams
Responsibilities: With some supervision from the RA Management, a Staff Regulatory Affairs Specialist is responsible for:
1. Preparing comprehensive regulatory strategies for device design and manufacturing process changes. Clearly communicates strategies to RA management, core teams, and business unit leadership
2. Preparing regulatory filings for new products, as well as product and manufacturing changes. As necessary, reviews complex regulatory issues with RA manager.
3. Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
4. Able to professionally negotiate directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues are negotiated with the RA manager.