Job Title: Global Regulatory Affairs Manager III
Location: Lake Forest
Contract Length: 12 months (could be extended to full 24 months)
Position Overview This position will independently provide tactical and strategic leadership on complex projects within the Global Regulatory Affairs organization by actively contributing to the development and implementation of global regulatory strategies throughout the lifecycle of medical devices.
Main Areas of Responsibilities:
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms. Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
Guide and influence technical groups in areas of product lifecycle management and enhancement.
Support the negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
Overall responsibilities include lifecycle management change analyses, project support, and needed submissions. This role will be directly responsible for submissions within the EU, US, and Canada and will support submissions in all other markets as needed.
Requirements
Experience in a medical device manufacturing facility/development laboratory preferred.
Develop and implement regulatory strategy aligned with business strategy.
Assess impact of new regulations and implement appropriate changes
Support the Initiation and maintenance of appropriate communication within the RA function and stakeholders
Interpret, apply and implement global regulations to projects and prepare regulatory submissions, particularly those in the US, EU, and Canada.
Actively participate in project team meetings and provide leadership in meeting submission goals
Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies
Preferred Skills/Qualification
Global responsibility for regulatory submissions (US, EU, and Canada)
Responsible for support of global registrations
Sound basis of Scientific (Training/Communications) knowledge in multiple areas
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Risk identification and problem solving skills
B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
MS degree and 4 years of regulatory experience.
PhD and 2 years of regulatory experience.
Must haves:
Change assessment experience for US and EU
Submission experience for US and EU, including STeDs, 510(k)s, and PMAs
Demonstrated leadership on complex regulatory strategies and projects
Wonderful to have:
Change assessment experience for Canada
Submission experience for Canada
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