Senior Program Manager, Regulatory Affairs - Critical Care
July 30, 2018
Full Time - Experienced
4 Year Degree
Join the global leader in hemodynamic monitoring. Our Critical Care business is seeking an experienced leader to provide RA leadership for the GlucoClear Division, while also providing support to the rest of the Critical Care Division.
As a Sr. Program Manager, Regulatory Affairs Critical Care you will play a key role in expanding our regulatory support across the critical care business. You will be responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations all the way from preparing submissions, including IDEs, 510(k)s, PMAs and design dossiers and technical files for CE marking, to obtain and maintain approvals for commercially distributing products worldwide to representing Regulatory Affairs on new product development and manufacturing support teams, as needed. You will also exercise judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents and may interact directly with regulatory agencies under management guidance.
Provide mentorship and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to market the Company’s products.
Represent Regulatory Affairs on project team and management review meetings, as needed.
Review advertising, labeling and public communications for regulatory compliance issues.
Review and approve design, development and operations change orders and software change orders.
Ensure compliance to design control regulations during product development and delivery activities.
Assist in developing regulatory strategy for new products and claims.
Responsible for keeping management team informed of regulatory status of products and significant regulatory issues.
Assist in representing the Company before US and international regulatory authorities.
Provide counsel, training, and interpretation of FDA and other regulatory requirements to Company personnel and assist as a liaison between the Company and regulatory authorities.
Assist in ensuring compliance to the Medical Device Directive (MDD)/ Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, and other regulatory requirements.
Support QA and QC in developing and executing compliance activities and corrective actions involving regulatory authorities.
Required Education and Experience:
A minimum of 12 years of applicable experience is required
Bachelor's degree in nursing, science or engineering is required; an advanced degree in the sciences, Ph.D., or a combination of an MBA or J.D. with a science degree is preferred.
A documented and recognized track record of bringing new products to market in the medical device industry with a strong preference toward the Critical Care monitoring or diagnostics market.
Possess a stellar Regulatory background and the ability to communicate effectively with both customers and industry thought leaders.
Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer’s and patient’s needs.
Continuously develops the talents of self and others for current and future business needs; motivates self and others to achieve high performance.
Good conceptual, analytical, problem solving, and organizational skills.
A “hands-on” individual, who enjoys challenge, is capable and dedicated to getting the job done with minimal support and direction in alignment with business needs.
An assertive, take-charge, proven regulatory professional with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
Ability to use common sense and judgment.
Well-organized and accustomed to maintaining excellent records.
Requires the ability to travel up to 30%.
Internal Number: 012968
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.