Senior Regulatory Specialist (Budapest)

Senior Regulatory Specialist (Budapest)
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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
  • Cafeteria
  • Bonus
  • 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.



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