Regulatory Affairs Specialist (m/w/d).

Job ID: 11091

Jetzt bewerben
Regulatory Affairs
Type of employment
  • Provide regulatory input to new product developments and product lifecycle planning for our clients products
  • Determine submission and approval requirements and keep regulatory submission timelines
  • Compile, prepare, review and submit regulatory submissions to authorities in cooperation with local country/regional Regulatory Affairs colleagues
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle
  • Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
  • Ensure compliance with product post-marketing approval requirements
  • Monitor validity of licenses, registrations and listings and renew in time
  • Assist in the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global RA group
  • Minimum Bachelors Degree in Science or Engineering
  • Minimum 3 years of Regulatory Affairs experience in the Medical Device industry, preferably with medical electrical devices
  • Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards and Global Regulatory submission requirements 
  • Ability for strong attention to detail in a complex work environment with multiple and competing registration priorities
  • Good planning and organizational skills
  • Basic analytical and problem-solving skills
  • Basic Project Management Experience, ideally with supporting new product developments and launches
  • Strong internal customer service orientation with “do whatever it takes” attitude
  • Strong team player
  • Experience working with SAP is preferred
  • Excellent English communication skills are essential, good German knowledge required