GE Healthcare, a leading global health technology provider has strong presence in Finland. We are 700+ people from over 25 countries, helping healthcare providers improve patient care. We're looking for Regulatory Affairs Leader who provides subject matter expertise for new product introductions and maintenance programs. You will work within a team of Regulatory Affairs professionals and with cross-functional program teams to ensure that global regulatory requirements are fulfilled.

Essential Responsibilities

• File/maintain regulatory deliverables
  
• Actively participate as team member on all assigned new product introductions and maintenance programs
  
• Create regulatory compliance/project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions  Create and file submissions; communicate with authorities regarding these submissions
  
• Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products
  
• Educate, train & advise others to ensure compliance with regulatory requirements
  
• Partner with Region RA for changes in existing products and license expiration requirements
  
• Provide RA oversight to clinical studies
  
• Support regulatory inspections

Qualifications/Requirements

• Bachelor’s Degree in scientific, technology or healthcare discipline or equivalent knowledge or experience
  
• Product related experience in the medical device or pharmaceutical industry or with medical product regulatory agencies
  
• Ability to prioritize, plan & evaluate deliverables to established strategic goals
  
• Proven application of analytical skills in a regulatory environment
  
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English
  
• Strong problem solving and negotiation skills
  
• Ability to work well independently & in a team setting
  
• EU working permit

Desired Characteristics

• Advanced degree in scientific, technology or legal disciplines or equivalent knowledge or experience
  
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, ANVISA, Health Canada, NMPA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
• Knowledge of Quality Management Systems (QMS)
  
• Experience with working across cultures/countries/sites 
  
• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
  
• Demonstrated understanding of healthcare environment
• Fluency in Finnish