Director of Global Regulatory Affairs (R&D)
The Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs and markets, with emphasis in US, EU and Latam.
As an expert within Regulatory, the Director will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.
Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory guidance for various corporate wide teams/committees. Will manage direct reports and have budget responsibility
Develops the global regulatory strategy for assigned programs through collaboration with a cross functional team
Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises team on changes that could impact future development.
Develops innovative life cycle management plans to achieve business objectives
Direct and lead regulatory authority meetings in different phases of product development
Direct the organization and preparation of clear and effective submissions.
Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communications via contact reports
Negotiates directly with regulatory authorities regarding company's filings.
Serves as regulatory affairs executive to provide input on Testing and filing activities and to ensure that report systems are maintained and compliant.
Collaborates with other departments as well as 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.
Represent Regulatory Affairs on cross-functional project teams
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the internal management teams as well as the executive management team.
Prepare and deliver effective presentations for external and internal audiences.
Responsible for line management and development of direct reports.
Identify areas in need of improvement and lead the development and implementation of process improvements.
Create an environment conducive to a global view as part of the whole regulatory team.
Manage team's employee development and succession planning activities; set performance objectives, provide coaching/guidance, and provide performance evaluation.
Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
A minimum 10-15 years Medical Device experience, of which at least 5 years is in Regulatory experience in International Markets.
Bachelors degree on a Life Science discipline; Master degree preferred.
Understanding of In Vitro Diagnostics and/or pharmaceutical Regulations is a plus
Experience in interpretation of regulations, guidelines, policy statements, etc.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
Demonstrated track record in securing product approvals and maintaining a complex portfolio
Extensive experience in interfacing with regulatory authorities.
Ability to lead and influence project teams, committees, etc. to attain group goals.
Demonstrated leadership and communication skills.
Ability to represent the department in project teams, committees and external meetings.
Demonstrate strong organizational skills, including the ability to guide, train, supervise and prioritize workload of direct reports, as required.
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
Well organized, detail oriented, effective written and oral communication skills.
Demonstrated experience on EU MDD & IVD regulations, EU CE Mark technical file documentation and overall submission process, as well as a solid understanding of the new EU MDR & IVDR regulations.
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/VeteranSee Job Description