Regulatory affairs team lead

We have partnered with a well known Surgical Devices organisation who are seeking a Regulatory Affairs Team Leader to be based out of Frankfurt, Germany. 

The organisation are a leading Ophthalmic surgical equipment manufacturer who are looking to add a Regulatory Affairs Team Leader to their growing team in the DACH region. The position will be responsible for international product registration of medical devices in the EMEA region, America, LATAM and APAC. 

Key Responsibilities:

• Management of direct reports, motivated teams, solve problems and make decision during the registration process. 
  • Monitor team productivity, provide constructive feedback and mentorship. 
• Support development of regulatory strategies, aligned with global strategies. 
• Planning & tracking registration of new productions. 
• Approval of new product submissions, change notifications and license renewal of authorities. 
• Establish, maintain and improve processes relating to product registration. 
• Provide regulatory input to the Global Submission Plan, ensure regulatory compliance.
• Ensure that promotional materials and marketing used is compliant with internal and external requirements. 

Experience / Skills Required:​

Functional Competency:

• Translate complex technical matter into understandable submission documentation
• Communicate effectively across departments 
• Organised structural way of working, adhering to guidelines
• Meticulous attention to detail 

Core Leadership Competency:

• Excellent interpersonal and communication skills with the ability to communicate effectively across departments
• Sense of responsibility 
• Ability to motivate people on your team and across departments

Education:

• Preferably a Bachelor or University degree in Science, Engineering and/or Biotechnology or equivalent relative experience. 

Experience:

• Hangling regulatory files and submission processes
• Experience with medical devices 
• Minimum 3 years' experience in Regulatory Affairs in Medical Device / Pharma industries. 

Travel requirements - occasional travel to other offices. 


To apply for this position, please submit your CV to James.Pickering@visionexecutives.com