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

MU5SZ2R1dnZCVk1nZ1NZaU01TVpITmJsS1E9PQ==
  • 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

Intermountain Health

Registered Nurse Interventional Radiology Job at Intermountain Health

 ...Registered Nurse Interventional Radiology at Intermountain Health summary: The Registered Nurse in Interventional Radiology provides specialized nursing care to patients undergoing diagnostic and interventional radiology procedures. This role involves assessing, planning... 

Crystal Clear Building Services

Part-Time Evening Cleaning in Columbus Ohio Job at Crystal Clear Building Services

 ...mopping, emptying trash, cleaning restrooms etc. M-F with some weekend availability 9:00pm - 1:00am. Pay rate $15.00hr. To schedule...  ...Ability to lift, bend, stand and walk for extended periods of time. Must be at least 18 years if age. Additional Information... 

GoldCoast Energy Solutions

Engineers (Commercial Nuclear Electrical, Mechanical, Civil/Structural) Job at GoldCoast Energy Solutions

 ...Replacement Projects. Develop design change packages in accordance with industry standards. Provide engineering support during nuclear power plant refueling outages. **Preferred Experience:** Mechanical: Industrial systems design, PEPSI Heat Balance modeling.... 

Indivior PLC

Medical Science Liaison (Portland, ME) Job at Indivior PLC

 ...TITLE: Medical Science Liaison (Portland, ME) Title: Medical Science Liaison Reports To: Associate Director, US Field Medical Ecosystems Location: Remote USA Indivior is a global pharmaceutical company working to help change patients' lives by developing... 

Welch Packaging Group Inc.

Electric Maintenance Technician Job at Welch Packaging Group Inc.

 ...employees to over one thousand employees. With customers at the core of our business philosophy, we have a service discipline that makes us easy to do business with. Through organic growth, strategic acquisitions, and a strong entrepreneurial spirit Welch Packaging...