Senior Regulatory Specialist
Your new company
Our partner is global leader providing a broad array of clinical diagnostics and life science research products
Your new role
- To manage the regulatory functions of the EEMEA sub region and to ensure that business is led in compliance with appropriate international and local country regulations.
- To be up to date with applicable standards and regulations and manage the process of local product registrations where necessary in EEMEA sub region. Scope of activity: Bio-Rad (incl. DiaMed & Biotest) products – EEMEA sub region countries (excluding Russia and CIS)
- To maintain appropriate records of Bio-Rad (incl. DiaMed & Biotest) ISO/FDA/IVD regulatory documents To coordinate, prepare or review regulatory submissions for the registration of products for EEMEA sub region countries with subsidiaries / channel partners and with manufacturing Business Groups.
- To maintain appropriate records of registration approvals and licenses, submitted to authorities.
- To coordinate the various languages regulatory needs from EEMEA sub region with Manufacturing Divisions.
- To work with local EEMEA sub region staff in Bio-Rad entities to maintain appropriate records for product compliance bodies, including, but not limited to IVD Directive IVD Regulation, FDA requirements and electrical safety regulatory bodies.
- To ensure that necessary licenses and certificates are kept updated and renewed as applicable and in timely manner.
- Coordinate execution of Field Actions in EEMEA. May participate in the training and development of other personnel across groups, divisions, and functional areas of the business.
- May participate in developing global regulatory strategies and tactics across groups, divisions, and functional areas of the business.
- May directly coordinate and lead cross-functional and/or cross-divisional project teams.
- Exerts a discernible but moderate impact on the short and long-range performance and success of the company.
What you'll need to succeed
- Bachelor’s degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- 10+ years related experience or equivalent combination of education and experience.
- Advanced degree preferred.
- Regulatory Affairs Certification is preferred.
- Project management experience is preferred.
- Advanced knowledge of FDA, CE Mark, and Global regulatory requirements policies, practices and procedures.
- Communication skills, including negotiation and persuasion.
- Analytical, problem solving, computer, and critical thinking skills.
- Ability to work independently.
- Flexibility through effective planning, time management and expertise.
- Thorough knowledge of policies, practices and procedures related to RA.
- Knowledge of Product Labeling and Export Requirements.
- Experience with Product Formulation, Device History Records/Batch Records, and FDA licensed biological products.
- Understanding of Weighing Procedures and Conversion Factors.
What you'll get in return
- Competitive compensation package
- medical service
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.