Regulatory Affairs Specialist III
RA Specialist III is primarily responsible to manage the Adverse Event Reporting and Field Action Process.
Additional responsibilities include initiating or updating procedures and work instructions at the corporate and local level, review and implementation of new and/or revised external standards/regulations.
- Responsible for Adverse Event Reporting Process including but not limited to assessment of escalated events, prepare and submit Medical Device Reports (MDR) and Medical Device Vigilance (MDV) as required.
- Responsible for Field Action Assesment process. Facilitate preparation, review, and submission of field actions as well as interact with FDA during field action review and submit responses as requested.
- Submit Field Corrective Actions, including reporting of Field Actions to U.S. FDA and Field Safety Corrective Actions to appropriate EU Competent Authorities as required.
- Prepare corporate and local standard operating procedures and work instructions.
- Participate in review and implementation of new and/or revised external regulatory standards.
- Participate in ECR/ECO process to review and approve changes made and assure compliance with the regulatory requirements and consistency with corporate standards.
- Additional responsibilities are assigned as required including but not limited to setting up regulatory restrictions in SAP and releasing blocked products, change management with subsidiaries, supporting audits etc
- Bachelor's degree, or equivalent, in Biology, Chemistry, Engineering, or related field.
- Minimum of 5 years experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics, with primary responsibility being assessment of potential adverse events and the field action process.
- Proficiency in interpretation and application of US regulatory requirements for IVD/Medical Devices/Biologics.
- Ability to manage multiple complex projects with defined timelines.
- Excellent written and verbal communication skills required for negotiation with internal and external parties.
Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative.
Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.