Regulatory Compliance Officer at Transport for NSW conducting investigations and audits for third party programs. Ensuring compliance with regulatory schemes and engaging with relevant programme participants.
WS
Hybrid Principal Specialist, Regulatory Affairs
Posted 3 weeks 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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