Collaborate with international colleagues to generate high quality submission dossiers to obtain medical device approvals in international markets.
Gather design and development information on products from cross-functional teams and submit on-time renewal applications to maintain existing registrations worldwide.
Develop regulatory strategies for countries outside of U.S to ensure speed to market while maintaining high standards of quality.
Assess global impact of product changes such as manufacturing, design, materials, technology, labeling etc. to determine course of action and develop regulatory strategy for implementation of such changes.
Conduct research on applicable product standards and guidance documents issued by health authorities worldwide and determine impact of proposed and current global regulations to propose suggestions for expediting approvals.
Previous experience in a Regulatory environment desirable.
Pharmaceutical or Medical Device experience preferred.
Experience in preparing domestic and international product submissions.
Knowledge of US, EU and international regulatory requirements.
Experience with design and development of medical devices.
Ability to manage multiple projects and deadlines and communicate priorities effectively.
Experience evaluating information to determine compliance with standards, laws, and regulations.
Well-developed oral and written communication skills.
Bachelor's Degree preferred.
Ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
Great team-player showcasing ability to work in a collaborative culture.
Portray critical thinking to understand complex information and convert/communicate it in a comprehensible manner.
Organize data packages in a clear and concise manner to enable smooth reviews of scientific information by external stakeholders.