Responsible for providing corporate compliance regulatory guidance and support to corporate
technology and product development projects including (but not limited to) development of
global regulatory strategies and management of global regulatory submissions. Additional
responsibilities include provision of regulatory support to Corporate programs and systems
development as well as coordination of the development and delivery of internal regulatory
training programs. Special projects may also be assigned on an as-needed basis. Candidate will
participate in multiple cross-functional project teams and therefore must be able to work
effectively with multiple disciplines and personalities. Due to the varied nature of this
position, candidate must be able to effectively manage and prioritize multiple projects. 30-40%
travel will be required.Successful candidate will have a minimum of 5 years Regulatory Affairs
or related experience in the medical device industry. Candidate's work experience must include
successful management, preparation and approval of premarket submissions to the FDA. Candidate
must be detail oriented and possess excellent interpersonal and communication skills (verbal
and written). A working knowledge of the implementation of Global medical device laws and
regulations (e.g., premarket requirements, QSR, MDR requirements, labeling, etc.) is essential.
Candidate must be proficient with office computer systems (PC platform, Microsoft Office
suite).
E-Mail to: 1830336.6@jobfrenzy.com
|