Category: Scientific & Clinical
Job Title: Director of Regulatory Affairs-Medical Device
Start Date: Immediate
- Develops technical content, format and accountability for regulatory submissions and related supplements and amendments.
- Advises project teams regarding the development and implementation of regulatory strategy through the analytic, GMP and clinical development processes.
- Establishes and maintains excellent relationships with regulatory agency personnel.
- Responds to requests for additional data, organizes and manages participation in meetings.
- Negotiates directly with regulatory authorities regarding company's filings.
- Reviews and approves technical data and verifies accuracy of clinical data and execution of preclinical and clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
- Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
- Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Reviews all external materials for regulatory compliance.
- Serve as overall global regulatory lead accountable for all regulatory aspects of assigned projects, including development and implementation of the global regulatory development plan for the project.
- Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
- Advanced education (e.g., MS, PhD, MD,) highly preferred.
- Valid passport and able to travel.
- Typically 15 years experience in the medical device industry.
- Management and leadership experience at project level, experience with strategic initiatives/issues.
- 12 years medical device regulatory affairs experience with regulatory processes including direct contact with regulatory agencies; full knowledge of FDA 510(k), EU CE Clearance & notified body regulations and guidelines, and the ability to provide interpretations of the information to others.
- Prior medical device regulatory affairs managerial experience, with direct supervision of senior level regulatory professionals or equivalent leadership role required.
- Strong knowledge of current US and EU regulations.
- Experience with developing and implementing competitive regulatory strategies.
- Solid understanding of dossier requirements for 510 (k), PMA, CTA, Design Master File, ISO 13485 and 21 CFR 820.
- Ability to strategically interpret and respond to requests from regulatory agencies.
- Demonstrated track record in securing product approvals and maintaining a complex portfolio.
- Direct experience of leading regulatory authority meetings in different phases of drug development.
- Proven leadership skills in a cross-functional team environment. International experiences a plus.
- Ability to interact externally and internally to support global business strategy.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Must possess knowledge and experience with FDA and EMA electronic authoring, global standards from ICH, GHTF (through IMDRF), WHO and ISO