GE Healthcare is a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. The Regulatory Affairs Director, RCIS is responsible for leading the overall Regulatory Affairs strategy and direction within the assigned area of responsibility (technical standards, laws and regulations, regulatory programs, etc).
Essential Responsibilities:
Scan the external environment and work with external
associations & global regulatory bodies, proactively adapt regulatory
strategies, and influence change within areas of responsibility.
Identify global regulatory trends & their
implications for GE Healthcare, taking into consideration the impact on
business decisions
Analyze & communicate proposed, new or changing
requirements and standards, & lead teams to develop strategies, programs
and processes to meet business objectives and ensure compliance with regulatory
requirements
Evaluate performance metrics to identify program
weaknesses & drive improvements in procedures or oversight.
Educate, train, advise & coach company professionals
to ensure compliance with RA requirements.
Work across GEHC to ensure a consistent approach to
regulations is adopted throughout the business within areas of responsibility.
Lead & support continuous improvement activities
with regard to areas of responsibility.
Recruit, mentor, coach and train direct and
indirect reports on activities within area of responsibility.
Qualifications/Requirements:
Bachelor’s Degree & minimum of 10 years’
experience in the medical device or medical product
regulatory agencies; OR minimum of 14 years progressive regulatory affairs
experience in medical device or medical product
regulatory agencies, including knowledge & experience applying device laws & regulations for product registration, adverse event
reporting, & recalls.
At least 2 years leadership experience, including
training and coaching of team members, ability to lead cross-functional,
cross-business teams.
Demonstrated knowledge of regulatory issues and
experience interfacing with local & internationals regulatory bodies
Demonstrated experience operating in a highly
regulated environment; Proven application of analytical skills in a regulatory
environment
Strong problem solving and negotiation skills with the
ability to develop and implement complex influencing and negotiating strategies
that demonstrate political awareness
Ability to work well independently and in a team
setting.
Excellent verbal and written communication and
presentation skills with the ability to speak and write clearly and
convincingly in English and Russian, tailoring communication methods to
customer’s requirements.
Must be willing to travel up to 15% of time
Successful candidates will be employed under local employment conditions and must already satisfy local employment/work permit and residency regulations.
Desired Characteristics:
Advanced degree in scientific, technology or legal
disciplines.
Regulatory Affairs Certification (RAPS).
Knowledge of Quality Management Systems
Experience working across cultures/countries/sites
Demonstrated experience prioritizing conflicting
demands from multiple business entities in an extremely fast paced environment.
Demonstrated ability to drive change, challenge the
status quo and champion new activities, stimulating others to change and manage
implementation effectively.
Demonstrated understanding of healthcare
environment and knowledge of current competitive, commercial or political
situations and their impact on GEHC regulatory strategies.
