Post Market Regulatory Affairs Analyst
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Post Market Regulatory Affairs Analyst for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Manages and supports overall compliance program. Performs research to understand requirements of pertinent federal, state and local regulatory schemes. Monitors operational compliance practices and performs risk assessments. Analyzes existing policies, identifies gaps and recommends new or revised policies and procedures, approval processes, and monitoring methods. Provides technical expertise in identifying and reducing areas of potential risk. Gathers data, conducts analyses, and prepares work related to compliance reviews. Participates in developing new compliance systems and tools to support large compliance projects. Required skills include the ability to partner with business personnel at various levels of the organization, strong verbal and written communication, analytical and project management skills.
Customer/Sales rep contact, Investigation writing, making FDA filing decisions.
Will need to ramp up product knowledge and understanding of processes/regulations
Interacting with engineers on service repair floor, evaluating/analyzing device evaluations.
Reviewing trending data and device history files, using risk documents to assess regulatory reporting decisions, reviewing service evaluations to assess for escalate for reporting, and complaint investigation results.
This role will be supporting a complaint process review.
SAP integration, will add add time and workload to the team.
Minimum years of experience required: 0-5 years, willing to train entry level in Complaint Investigation if past background matched
Bachelor s degree required
Top 3 MUST-HAVE Skills:
o 1. MS Office proficient
o 2. Organization/Ability to prioritize
o 3. Critical Thinking
Top 3 Desired Skills:
o 1. Trackwise experience
o 2. People skills
o 3. Medical Device/Regulatory experience