What are the responsibilities and job description for the Regulatory Affairs Specialist position at Entegee?
W2 Contract
Onsite in Boulder, CO
45-65 / HR
Sr Regulatory Affairs Specialist
HM's Top Needs :
Experience with US and EU change assessments
Medical Device
Experience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author)
- Willingness to be adaptive, collaborative, and supportive of the Regulatory team
- Bachelors Degree and 4 years of regulatory affairs experience
The senior RA specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions.
Responsibilities
Provide strategic input and technical guidance on regulatory requirements for product modifications
IDE and PMA Annual Reports, IDE Supplement, PMA Supplement, MDD and MDR STED updates and EU MDR submissions.
Manage multiple projects and prioritize tasks to meet project schedules
Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
Participate in internal and external audits as needed
Equal Opportunity Employer / Veterans / Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
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The Company will consider qualified applicants with arrest and conviction records .
