Job Description :
Job Position: Business Analyst with Healthcare/Medical device experience is MUST.
Job Location: Bridgewater NJ

Required Skill Set:
10+ years of working knowledge in health care domain preferably in pharma/medical devices industry.
Good working experience in healthcare industry in clinal and regulatory activities
Must have an in-depth knowledge of Industry standard data model - FHIR
Strong experience in gathering, understanding and documenting business requirements by working closely with business team and document testable requirements accordingly.
Ensure that the GxP system meets the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines
Work closely with IT teams to establish initiatives and strategies to improve and to optimize product quality
Ability to translate business requirements to functional requirements
Ability to iterate specifications and solutions efficiently and logically
Ability to effectively communicate processes, ideas, and solutions to teams and clients
Good to have:
Understanding of regulatory, pharmacovigilance and reporting requirements and the related guidelines/ policies with medical background
Ability to successfully collaborate with other stakeholders.
Ability to effectively conduct meetings, both formal and informal, including departmental and clinical user meetings.
Possess strong problem solving and negotiation skills