Regulatory Data Compliance specialist

POSITION DUTIES & RESPONSIBILITIES

The Compliance Specialist’s primary responsibilities are:

• Collect, upload and maintain medical device electronic master data within global Regulatory databases and repositories

• Perform audits of the medical device master data to ensure proper revision control and adherence to local/global SOP’s

• Ensure Regulatory staff is following global Regulatory SOPs and processes through compliance monitoring and the implementation of training initiatives when needed

• Help identify and support the implementation of process and database improvement initiatives

• Participates in the assessment and/or implementation of Regulatory IT systems

• Maintain accurate records and communicate database / project status to teams

A successful candidate will:

• Be detail oriented, having the ability to focus on details while still seeing the broader picture

• Have a passion for compliance and organization

• Be able to manage and effectively analyze large quantities of data

• Be expected to work well autonomously and as part of a collaborative team

• Demonstrate interpersonal and communication skills, including an ability to establish good working relationships with diverse individuals

• Manage time well and prove ability to meet deadlines

• Be able to work independently and under supervision

• Have proven communication skills

• Be proactive in identifying data discrepancies and help resolve them on a timely basis.

REQUIREMENTS/PREFERENCES

• Minimum 0 – 2 years of experience working in a regulated industry.

• Bachelor’s degree in an IT, Engineering, or Science discipline

• Experience using Microsoft Office and other information management systems.

• Previous experience with database management and compliance activities is strongly preferred.