Quality & Regulatory Support Specialist; Remote

Position: Quality & Regulatory Support Specialist (Remote)
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at  to learn more and view our open positions.

Please apply or call one of us to learn more For further inquiries regarding the following opportunity, please contact our Talent Specialist, Hari at

Title:

Quality & Regulatory Support Specialist (Remote)

Location:

Remote Duration: 3 Months Must be able to work either 6 AM - 3 PM or 7 AM - 4 PM Monday-Friday Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description:

Purpose of Position (i.e. projects involved with and role within group):
Responsible for providing front line support for internal and external customers regarding quality and regulatory related inquiries and issues, predominantly for our customers in Europe. Support of customer communications regarding complaints and audit requests. Facilitate customer audit requests working with customers and Plant Quality to schedule on-site and remote audits. Assure that all necessary components and agreements are in place prior to customer audit.

Act as liaison between customers and other Client departments and functions. Responsible for supporting the projects and ongoing processes associated with Quality and Regulatory Services (QRS) Day to Day Responsibilities:
First level triage of customer complaints and QRS email queue. Sort incoming emails quickly, identify duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines Escalate key customer and urgent inquiries to the correct department as needed on demand according to QRS guidelines Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction Key Decision Areas Daily priorities as well as timely positive professional communications to external customers, business colleagues and teams Criteria for Performance Evaluation Work targets and schedules are met QRS guidelines and policies are followed, including use of email templates for customer communication Effectively, positively & professionally interact with internal and external customers Demonstrates cooperative daily positive interactions with Customer Service, Quality and Regulatory, Supply Chain, Scientific Support, Sales and Business Operations teams regarding distributors and customers' needs / requests Able to appropriately determine which inquiries and issues should be escalated, and follow escalation paths as defined by QRS procedures Required Skills Demonstrated capacity for handling time sensitive varying customer requests and prioritizing/escalating tasks accordingly Skilled in all Microsoft Office applications.

Ability to quickly learn and adapt to new systems. Customer facing, manufacturing and/or Quality/Regulatory experience in medical device and/or clinical industries Courteous, articulate and professional oral and written communication skills Desired Skills Experience designing and maintaining reports and metrics Knowledgeable in use of ETQ, Sharepoint, , SAP, and People Soft. Passion for innovation, automation, and continuous improvements Multi-lingual skills highly desired

Education and Experience (minimum required for consideration) Bachelor's degree, Life Sciences, Chemistry or…