Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
About the role
- Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Responsibilities
- Provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit’s drug product.
- Interacts with the business unit’s cross-functional leadership team to support the direction, strategy, and growth of the organization.
- Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
- Creates long term regulatory strategy for drug products.
- Manages a regulatory affairs team responsible for the division’s pharmaceutical products.
- Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
- Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
- Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.
Requirements
- Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
- Minimum 15 years of experience, including 10 years in an FDA regulated industry
- 5 years of managerial experience preferred
- Experience with successful NDA and DINAs.
- Prefer additional experience with IDEs/ 510(k)s and/or combination products.
Benefits
- salary plus bonus eligible
- generally eligible for short-term and long-term financial incentives
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