Director, International Regulatory Affairs K2M
THIS JOB HAS EXPIRED Responsible for leading the company?s international (ex-USA) regulatory affairs program. Salient aspects incorporate the planning of regulatory submission strategies, maintaining up-to-date regulatory requirements by country and ensuring regulatory compliance for cleared and approved products for the international market.
Representation on key external bodies to foster the interests of K2M is an important part of the role, together with internal representation on product development teams.
Device submissions internationally (ex. USA).
Expert on international regulatory affairs issues.
Representation internally on product development teams from regulatory perspective.
Representation externally on one or two key committees of benefit to K2M, e.g. AdvaMed, AAMI, ISO, OSMA etc.
Cover for U.S. FDA position.
Support to business initiatives in International geographies, e.g. South America.
BA/BS Degree required and a minimum of 5 years experience managing global regulatory submissions
Experience in managing regulatory submissions in multiple countries
Expertise in orthopedics and knowledge of spinal systems.
Knowledge of the U.S. FDA regulatory submission processes to allow for cover.
Demonstrated leadership and strategic planning abilities.
Excellent presentation skills.
Strong internal and external communication skills; adept at public speaking.
Strong selling skills and ability to influence Key Opinion Leaders.
Highly organized with ability to multitask.
Excellent computer skills with proficiency in Word, PowerPoint, and Excel.
Ability to travel approximately 30%.
||751 Miller Drive, SE |
Leesburg, VA 20175
THIS JOB HAS EXPIRED