Regulatory Affaris Specialist - Temporary
Tri-Valley Career Center, Irvine, CA, United States
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio‑Rad products currently CE Marked under the IVD Directive. Activities include preparation and revision of technical files when needed, updating labeling to comply with IVDR requirements, tracking RA regional notifications, and other related activities.
How You'll Make an Impact
Support the IVDR project by revising assigned technical files using the latest template and presenting product characteristics and performance to demonstrate conformity evidence. Include latest technical reports, validations, test reports and other documents from the technical file table of contents, and complete each file within the defined timeline. Attend multiple weekly meetings to address issues and keep the project manager informed.
Support the IVDR labeling conversion project, participating cross‑functionally and attending weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request numbers. Update labeling specifications to meet IVDR requirements as needed.
Support tasks to un‑CE‑Mark selected products and track work until final labeling reflects desired changes per the labeling specification.
Update the technical file tracking log, notify and track RA regional notifications of labeling changes, and notify the RA SAP restriction coordinator when specific product lots must be restricted to prevent distribution in certain regions.
What You Bring
Bachelor’s degree in biochemistry, biology, medical technology or a related field.
3–5 years of experience in regulatory affairs, QA, R&D, manufacturing or project management in the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products is a plus.
Ability to work independently and collaboratively.
Strong communication skills, including negotiation and persuasion.
Analytical, problem‑solving, computer and critical‑thinking skills.
Thorough knowledge of policies, practices and procedures related to regulatory affairs.
Compensation
The estimated hourly range for this position is $45 to $50 at the time of posting. Actual compensation will be provided in writing at the time of offer and is based on factors such as geographic location, experience, knowledge, skills, abilities, and other permissible job factors. As a temporary associate, employment will be managed directly through our approved agency provider.
EEO Statement
Bio‑Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
#J-18808-Ljbffr
How You'll Make an Impact
Support the IVDR project by revising assigned technical files using the latest template and presenting product characteristics and performance to demonstrate conformity evidence. Include latest technical reports, validations, test reports and other documents from the technical file table of contents, and complete each file within the defined timeline. Attend multiple weekly meetings to address issues and keep the project manager informed.
Support the IVDR labeling conversion project, participating cross‑functionally and attending weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request numbers. Update labeling specifications to meet IVDR requirements as needed.
Support tasks to un‑CE‑Mark selected products and track work until final labeling reflects desired changes per the labeling specification.
Update the technical file tracking log, notify and track RA regional notifications of labeling changes, and notify the RA SAP restriction coordinator when specific product lots must be restricted to prevent distribution in certain regions.
What You Bring
Bachelor’s degree in biochemistry, biology, medical technology or a related field.
3–5 years of experience in regulatory affairs, QA, R&D, manufacturing or project management in the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products is a plus.
Ability to work independently and collaboratively.
Strong communication skills, including negotiation and persuasion.
Analytical, problem‑solving, computer and critical‑thinking skills.
Thorough knowledge of policies, practices and procedures related to regulatory affairs.
Compensation
The estimated hourly range for this position is $45 to $50 at the time of posting. Actual compensation will be provided in writing at the time of offer and is based on factors such as geographic location, experience, knowledge, skills, abilities, and other permissible job factors. As a temporary associate, employment will be managed directly through our approved agency provider.
EEO Statement
Bio‑Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.
#J-18808-Ljbffr