190664 - Post-Market Surveillance Specialist
Industry
PRO
Region
CA-Central California
City
Fremont
State
CA
Rate
Up to $45.00 DOE
Duration
8 MOS
Description
Chipton-Ross is seeking a Post-Market Surveillance Specialist Post-Market Surveillance Specialistfor an opening in Fremont, CA.

RESPONSIBILITIES:
Generate post-market surveillance plans, reports, and other required documents as required to support IVDR. Analyze and interpret clinical and PMS data.
Work with project team to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF). Support internal and external audits. Assist with the post-market Risk Management process. Support RA assessments and supportive processes as needed.

REQUIREMENTS:
3-5 years of post market regulatory affairs experience in medical device, biotech, life sciences or related fields. Excellent written and verbal communication skills working in a team environment.

Desired
Solid knowledge of GMP/FDA QSR/ISO 13485, ISO 62304, ISO 14971 and other medical device standards.

EDUCATION:
Accredited BS/BA Degree in a science related field.

WORK HOURS:
Full-Time
M-F, 8 AM to 5 PM

Remote work okay but candidate must be local

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Andrew Craft
acraft@chiptonross.com
CHIPTON-ROSS, INC.
11832 Fishing Point Drive, Suite 100
Newport News, VA 23606

Phone: (757) 595-0005 x173 or (877) 244-5418 x173

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.