Randstad Regulatory in Pleasanton, California
salary:$82.86 - $97.48 per hour
date posted:Thursday, August 9, 2018
Regulatory Affairs Consultant II
Works as team lead on regulatory submissions deliverables to ensure compliant, successful, on-time market clearance/approval.
Is a regulatory subject matter expert regarding active medical devices including software.
Capable of handling multiple requests from regulatory agencies, simultaneous product registrations and submissions to regulatory bodies.
Also able to maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections.
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Provide significant regulatory strategy development and support.
Education & Qualifications
Bachelor's /Master's degree or equivalent; RAC certification preferred.
Expert level global regulatory submissions experience required.
Minimum 10 years professional experience in medical devices Regulatory Affairs (RA).
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.