Lead compliance oversight for the Pan European Citco entities. Build stakeholder relationships and manage compliance risks across the organization.
WS
Hybrid Principal Specialist, Regulatory Affairs
Posted 2 months ago
About the role
- Principal Specialist in Regulatory Affairs developing global regulatory strategies for medical devices. Collaborating with cross-functional teams to ensure compliance and prepare submissions for market approvals.
Responsibilities
- Develop and implement medical device regulatory strategies for administration and safety systems
- Author and review complex product submissions guidance and negotiate submission issues with Agency personnel
- Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams
- Prepare US, EU, and other international submissions for new products and product changes
- Work with RA team to build Regulatory strategies for medical device development platform
- Provide leadership to product development teams for regulatory issues and questions
- Provide support to market-released products as necessary
Requirements
- Bachelor's Degree science, math, engineering, life sciences or related discipline required
- Minimum 8 years related work experience required
- Medical device or Combination Product regulatory experience preferred
- Excellent oral communication and technical writing skills
- Advanced knowledge of product life cycle, product development, design control and change control
- International regulatory competency
- Experience with administration and safety systems preferred
- Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745)
- History of successful US 510(k) device and EU technical documentation submissions
- Experience directly interacting with government agencies
- Strong negotiation and decision-making skills
Benefits
- Generous Paid Time Off (PTO)
- Global Career Opportunities
- Inclusive & Collaborative Culture
- Recognition & Rewards
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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