The Staff Regulatory Affairs (RA) Specialist is responsible for establishing and maintaining regulatory operating systems and databases, performing change control assessment, reviewing/approval product labeling, and conducting training. He/she is responsible for assisting Sr. Director of Regulatory Affairs to ensure department processes and procedures related to regulatory responsibilities are compliant, current and efficient.
- Maintains, updates and creates (when deemed necessary) Regulatory department procedures and databases.
- Acts as the main Regulatory contact to assess impacts of product and process changes to registrations worldwide.
- Reviews and approves product labeling.
- Leads regulatory training.
- Assists in the preparation and submission of regulatory documents.
- Monitors FDA, EU and other agency laws, regulations, and standards changes associated with BDB products, and communicates the changes to Regulatory leadership.
- Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in regulatory topics.
- Performs other duties and assignments as required.
Education and Experience:
- Minimum B.S. degree in life science field (molecular biology, biology, microbiology, chemistry, etc.). M.S. and/or Ph.D. a plus.
- Project management certifications or regulatory/quality certifications (RAC, CQA, CQM, etc.) encouraged.
- Minimum of 5 years directly applicable regulatory experience (regulatory system set-up, maintenance, change controls, label review, etc.) in an IVD or medical device company.
Minimum knowledge and skills:
- Familiar with IVD or Medical device regulatory systems.
- Demonstrated strong organizational and planning skills, including action oriented, focused urgency and driving for results
- Demonstrated self-starter, learning agility, multitasking skills, and positive attitude.
- Demonstrates excellence in both oral and written communication within the department, between functional groups, and externally. Prepares formal written reports/documents for distribution within and external to the department.
- Fosters collaboration among team members.
- Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint)
Job ID R-18049