Regulatory Affairs Associate - 27832

Guidant Corporation researches, manufactures and markets systems for cardiac rhythm management, vascular intervention and cardiac/vascular surgery worldwide. Our mission is to provide innovative, therapeutic medical solutions of distinctive value for our customers, patients and health care systems around the world. In our industry, we have always been known for leadership and innovation, and for an organizational structure that allows employees freedom to grow.

 

Regulatory Affairs Associate

Santa Clara, CA

CS/I-MB/27832

 

The Regulatory Associate is responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the Associate is responsible for assessment of device changes for regulatory implications.

 

Develop strategies for regulatory approval of medical devices.

Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.

Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes. (Some activities are CRM only)

Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization. Coordinate Guidant comments on proposed regulations.

Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.

Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.

Participate in training and mentoring of staff.

Coordinate IFU development activities (VI & ES only).

Participate in department systems development initiatives.

 

Position Qualifications Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.

Posting ID 15354BR

 

Guidant offers a company environment of market leadership, product innovation and personal growth, plus excellent benefits, including medical, dental, vision and life insurance, short and long-term disability, paid vacations and holidays, 401(k), retirement ESOP, annual bonus, paid year-end shut down, and tuition reimbursement.

 

For further details about this position and to apply, please visit: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=95&siteid=5184&AReq=15354BR&Codes=I-MB

 

Guidant is an Equal Opportunity Employer and maintains an Affirmative Action Program.