Regulatory Affairs Associate - 30670

Follow your aspirations to Abbott for diverse opportunities, competitive salaries and great benefits, all with a company providing the growth and strength to build your future.

 

Regulatory Affairs Associate- Abbott Endovascular Sales

Temecula, CA

VI/MB/31658

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 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.

Additional Information Candidate will have direct experience with intravascular medical devices and related FDA and global regulations governing approval or clearance of said devices. Direct experience with 510(k) / PMA processes and Design Dossier / Technical File processes is required. Some travel will be required between Temecula and Santa Clara (once or twice per month). THIS POSITION IS SEATED IN TEMECULA.

Posting ID 18282BR

Benefits:

Comprehensive and market competitive benefits and compensation package included.

 

Abbott welcomes and encourages diversity in our workforce. EEO/AA

 

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=18282BR&Codes=I-MB