Senior Clinical Compliance Associate: Edwards Lifesciences LLC

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine , Calif. , Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees 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 help ensure that patients regain and even improve their quality of life.

Senior Clinical Compliance Associate

Opportunity Snapshot:

Responsible for performing a wide variety of activities pertaining to assuring compliance with global operating procedures and regulatory requirements for Clinical Operations.
Will assist in SOP development, maintaining and training, as well as templates, forms and other study related documents for Clinical Operations.

Key responsibilities:

•Develop work plans and schedules for compliance monitoring of multiple concurrent clinical study projects with progressively less oversight.
•Deliver completed compliance monitoring reports within established time frames and standards.
•Participate in departmental and/or corporate quality initiatives.
•Maintain a working knowledge of current and proposed laws, regulations and guidelines.
•Support the management of internal and external compliance monitoring of Edwards Lifesciences operations.
•Provide guidance to Edwards Lifesciences facilities regarding regulatory compliance and internal policies and procedures.
•Review and provide feedback on clinical protocols, CRFs, Clinical Study Reports and other clinical documents.
•Conduct compliance monitoring visits for clinical study sites
•Assist in compliance monitoring training and clinical affairs training
•Oversee compliance with establishment registrations

Our Requirements:

The Clinical Compliance Associate III level requires a minimum of four years related work experience within the medical device industry or other regulated industry; and the Senior Associate, Clinical Compliance level requires a minimum of five years experience within the medical device industry or other regulated industry. Prior work experience in Clinical Monitoring, Quality Assurance/Control or Regulatory Compliance is required. Experience with site monitoring is a plus.

A Bachelors degree is required, preferably in a scientific or related discipline.

Knowledgeable on diverse regulations and standards such as: 21 CFR Part 11/50/56/ 801/803/806/807/820/812/814/821/822,
ISO 14155; ICHs, and other applicable regulations.

*Position title and level posted is preferred. However, depending on experience, we will consider hiring within these levels: Clinical Compliance Associate III or Senior Associate, Clinical Compliance.

How to Apply:
At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website:
www.edwards.com

OR

To apply directly to this position, please click the link below or cut and paste it into your browser:
http://www.edwards.com/Careers/reqfinder?urlvariablestring=3544

***Note to Agencies and Recruiters: Edwards Lifesciences is not accepting referrals from Agencies or Recruiters.

Resumes received by Edwards Lifesciences from search firms and/or individual recruiters are considered unsolicited.

Agencies and Recruiters: Refrain from contacting managers directly, to solicit job orders. Contact the Edwards Lifesciences Human Resources Department via e-mail at EW_Talent_Acquisition@edwards.com or call our dedicated Talent Acquisition hotline at 949-250-3422. Thank you.