Senior Specialist, Int’l Regulatory Affairs - Critical Care
July 30, 2018
Full Time - Experienced
4 Year Degree
Create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada]).
Represent the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
Provide guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects, based on prior experience and responses from affiliates.
Other incidental duties designed by Leadership.
A Bachelor’s degree with 5 years of related experience is required.
A Bachelor’s degree in a scientific discipline (e.g. Biology, Microbiology, Chemistry) with 5 years of related experience in preparing domestic and international product submissions is preferred.
Experience with class II medical devices is a plus.
Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
Full knowledge and understanding of global regulatory requirements for new products or product changes.
Full knowledge of new product development systems.
Coursework, seminars, and/or other formal government and/or trade association training required.
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
Good written and verbal communication skills and interpersonal relationship skills.
Good problem-solving, organizational, analytical and critical thinking skills.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Sensitive to other cultures.
Ability to manage competing priorities in a fast paced environment.
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
Ability to build productive internal/external working relationships.
Works independently without close supervision.
Compares and evaluates possible courses of action after considering various possibilities.
Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.
Considers the cause and effect of activities.
Determines or effectively recommends course of action after considering potential risks of alternatives.
Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment.
Direction tends to be high level and focused on end results with means of accomplishment left to incumbent.
Fluency in Japanese and knowledge of the Japanese culture is preferred.
Internal Number: 013880
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.