Director, Regulatory Affairs - Critical Care
Location: Irvine California
Description: Edwards Lifesciences is in need of Director, Regulatory Affairs - Critical Care right now, this career will be placed in California. Further informations about this career opportunity please read the description below. Join the global leader in hemodynamic monitoring. Our Critical Care business is seeking an experienced leader to provide RA leadership for the GlucoClear Div! ision, while also providing support to the rest of the Critical Care Division.
As the Director, 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 which is a key resource. You will also exercise independent 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.
Additional resp! onsibilities include:
Provide management and leadershi! p to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes;
Responsible for Company’s Worldwide Regulatory filings, and obtaining the required regulatory approvals to market the Company’s products;
Represent Regulatory Affairs on project team and management review meetings;
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 co! unsel, 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) 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;
Qualifications
A minimum of 15 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 back! ground and the ability to communicate effectively with both customers a! nd 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;
An assertive, take-charge, proven manager 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, to build, motivate and manage a strong regulatory organization;
Well-organized and accustomed to maintaining excellent records;
Requires the ability to travel up to 30%
About! Edwards
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 about 8,000 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.
Job Function
:
Regulatory Affairs
Primary Location
:
USA-California - Irvine
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If you were eligible to this career, please email us your resume, wit! h salary requirements and a resume to Edwards Lifesciences.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Fri, 05 Apr 2013 01:03:56 GMT