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

STVMRHhCSU9Cb0Z5aml4czhJaklod3NwT0E9PQ==
  • Tucker Parker Smith Group (TPS Group)
  • Irvine, CA

Job Description

Regulatory Affairs Specialist (IVDR)

Location: Irvine, CA. (HYBRID T/TH 3rd day of choice )

12 Month Assignment (Potential to Extend)

Pay rate $45–$50/hr. DOE

On behalf of our client a medical device company we are seeking for a Regulatory Affairs Specialist to support in their transition efforts for the EU’s In Vitro Diagnostic Regulation (IVDR). This role will play a critical part in ensuring all CE-marked IVD products comply with the latest regulatory requirements. The position involves technical file preparation, labeling updates, regulatory notifications, and cross-functional project coordination.

Main Responsibilities:

  • Ensure technical files clearly describe product characteristics, performance claims, and evidence of conformity.
  • Compile required documentation (e.g., validation reports, test data) into each technical file per the defined table of contents.
  • Support the IVDR labeling conversion project in collaboration with cross-functional teams.
  • Update the labeling conversion tracking log using manufacturing schedules, fill dates, lot numbers, and change request information.
  • Modify labeling specifications as needed to meet IVDR standards.
  • Product De-Certification Support
  • Assist with the process of un-CE marking selected products.
  • Ensure all associated labels reflect the removal of the CE mark according to defined specifications.
  • Maintain technical file and labeling tracking logs.
  • Coordinate regional regulatory notifications and document changes appropriately.

Qualifications:

  • Bachelor’s degree in Biochemistry, Biology, Medical Technology, or related field.
  • 3+years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.
  • Working knowledge of FDA and CE marking requirements is highly desirable.
  • Proficient in Microsoft Office and regulatory documentation systems.

Please submit a copy of your resume in Word or PDF format to be considered.

Job Tags

Work at office,

Similar Jobs

Pomeroy Living

Housekeeper Job at Pomeroy Living

Join the Pomeroy Living Team! Pomeroy Living is seeking a Housekeeper to join our team. You will play a vital role in maintaining a clean and welcoming environment for our residents and staff. Responsibilities: Clean and maintain resident apartments, common...

Millman Search Group

Facilities Manager Job at Millman Search Group

 ...About the Role: Our client is hiring a full-time, on-site Security & Facilities Manager to lead day-to-day operations of a mall/shopping center. This person will be responsible for security, maintenance, and cleaning and will personally cover one of the daily... 

Front Page Agency Inc

Entry Level Project Manager Job at Front Page Agency Inc

&##128640; Entry-Level Project Manager (On-Site) | Training + Big Growth Ahead! Launch Your Career in Sales, Strategy, & Leadership with Front Page Agency Inc. Are you ready to take your potential to the next level? Front Page Agency Inc., one of Austins top consulting... 

Insight Global

Heavy Equipment Mechanic Job at Insight Global

 ...JOB DESCRIPTION: A state and local client is looking for an Automotive Mechanic to join their team! The successful candidate will be responsible for performing comprehensive maintenance and repair services on a fleet of vehicles such as police cars, dump trucks, and... 

Insight Global

Copywriter Job at Insight Global

 ...craft compelling writing across a variety of platformsincluding social media, digital and print ads, email campaigns, websites, and video...  ...of current entertainment trends, audience behavior, and brand voice is essential, along with the ability to present ideas clearly...