Bio-Rad is looking for a Regulartory Affairs Specialist.
- Provide regulatory support to currently marketed products
- Support product registrations to assure timely release of new product to market
- Insure incidents and recalls are properly managed
- Provide regulatory advice to local stakeholders and Global RA/QA
- Interact with regulatory agencies
- Participate in audits and regulatory agency inspections as needed and assists in dispersing the information as appropriate.
- Fully bilingual, French and English
- Bachelor's degree or graduate studies in biochemistry, microbiology, immunology, medical technology or related field.
- An advanced degree and/or Regulatory Affairs certification are preferred. Blood banking would be an asset.
- Five or more years of experience in regulatory affairs, clinical laboratory testing environment and/or manufacturing within the IVD industry.
- Experience in a regulated environment (GMP and/or ISO 13485).
- Some experience working with ERP (enterprise resource planning) systems , SAP in particular.
- Superior reading and writing skills in both French and English
- Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skills.
- Strong documentation and organizational skills
- Understand the software validation requirements
- Able to work independently and with others
- Excellent computer applications skills and able to perform basic statistical analysis
- Strong critical thinking and problem solving skills
- Strong customer orientation and focus
- Strong tact and negotiation skills
Thorough understanding of ISO standards, Good Distribution Practices (GDP), and Health Canada requirements as they apply to products licensed and distributed by Bio-Rad.
Bio-Rad is an Equal Opportunity Employer and welcomes all qualified applicants.