Regulatory Affairs Specialist Job at Tucker Parker Smith Group (TPS Group), Hercules, CA

SHAxTEZ1YnJxeWpHL1F2dlBKRWI5UGE3dmc9PQ==
  • Tucker Parker Smith Group (TPS Group)
  • Hercules, CA

Job Description

Regulatory Affairs Specialist I - Clinical Diagnostics (IVD)

Hercules, CA 94547 | Hybrid (2 days on-site + 1 flexible day after 30 days)

$40/hr | 1-Year Contract - high potential to extend or convert

Join a top-tier biotech and medical manufacturing company at the forefront of clinical diagnostics.

Are you detail-oriented, organized, and ready to contribute to impactful regulatory work? Our client is seeking a Regulatory Affairs Specialist I to support global product registration and IVDR compliance for in vitro diagnostic (IVD) devices. You'll collaborate cross-functionally with Marketing, R&D, QA, and Manufacturing teams to ensure products meet regulatory requirements worldwide. Experience in the IVD industry is essential to support technical documentation, SOP improvements, and global submissions across multiple diagnostic product lines.

What You'll Do:

  • Assemble regulatory submissions for IVD products across multiple product groups
  • Maintain IVDR technical files and monitor change requests
  • Support SOP improvements tied to IVDR transition
  • Communicate daily with technical writers, publishers, and regulatory teams

What You Bring:

  • Bachelor's degree in Biology or a related scientific field
  • 1+ years in IVD regulatory affairs
  • Laboratory research experience in an IVD medical device regulated environment is strongly preferred
  • Familiarity with scientific reports, risk management, and Quality Systems
  • Proficiency in MS Office and comfort working in electronic systems (e.g., Excel, Word, PowerPoint, Teams)

Job Tags

Contract work, Worldwide, Flexible hours,

Similar Jobs

Spiezle Architectural Group, Inc.

Architectural Project Coordinator Job at Spiezle Architectural Group, Inc.

 ...you to work on both local and national projects. A role with construction documentation...  ...industry standards, and relevant code Coordinate technical aspects of the project with internal...  ...the weekend The ability to work remote up to 2 days a week once acclimated! Flexible... 

Prisma International

Onsite Interpreter (OSI) - Washington, D.C. Job at Prisma International

 ...accredited through a higher education institution PAY:$53.00 - $69.00 per hour SECURITY REQUIREMENTS: Interpreters must have a valid background check to provide. DESIRED SKILLS: ~ Experience working with agencies such as FEMA, USCIS, CBP, DHS, etc.... 

UNMHSCHS

STERILE PROCESSING TECH Job at UNMHSCHS

 ...Compensation for this role is based on a number of factors, including but not limited to experience, education, and other business and organizational considerations.Department: Sterile ProcessingFTE: 1.00Full TimeShift: RotatingPosition Summary:Provide operational... 

Sarah Bush Lincoln

Entry-Level Pharmacy Technician - PRN Job at Sarah Bush Lincoln

 ...Workday and applying through the Jobs Hub before proceeding.Entry-Level Pharmacy Technician - PRNJob DescriptionPharmacy...  ...are responsible for assisting Pharmacists in all aspects of pharmaceutical care including processing and distribution of all drug and IV... 

Sea Mar Community Health Centers

Health Educator I or II Job at Sea Mar Community Health Centers

 ...Sea Mar Community Health Centers, a Federally Qualified Health Center (FQHC) founded in 1978, is a community-based organization committed...  ...to providing quality, comprehensive health, human, housing, educational and cultural services to diverse communities, specializing in...