Regulatory affairs specialist - in-vitro diagnostics

job summary:
Advance your career in beautiful San Diego! A Top-Tier Global Life Sciences Leader is seeking a Regulatory Affairs Specialist III for a hybrid role (3 days onsite). This position offers an exciting opportunity to independently lead regulatory strategies for high-scrutiny In-Vitro Diagnostic (IVD) blood-screening product lines, collaborating closely with R&D to bring next-generation testing technologies to the global market.

Prior experience in the IVD or Biologics industry is required.

location: San Diego, California
job type: Permanent
salary: $100,000 - 132,000 per year
work hours: 9 to 5
education: Bachelors


responsibilities:

• Prepare and file complex pre-market and post-market regulatory submissions with the US FDA, EU Notified Bodies, and other international authorities.
• Develop and execute global submission strategies for high-risk in vitro diagnostic (IVD) products from concept to commercialization.
• Partner with R&D and cross-functional teams to translate complex technical and scientific data into comprehensive regulatory documentation.
• Independently manage correspondence with health agencies, authoring clear and timely responses to inquiries.

qualifications:

Education

Bachelor's Degree required in the life sciences, engineering or similarly related field

Experience

6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Biologics Industry experience required

Minimum 4 years experience in Reg Affairs supporting highly regulated IVD products (CBER-regulated BLAs, Class D for EU IVDR) or non-device BLAs as long as they are above Class I / Class A.

skills: FDA Submissions, Life Cycle Management Regulatory Perspective, Global Regulatory Strategy Execution


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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on click.appcast.io.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


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.