Quality and Regulatory Affairs Associate

(*can be part time position)

To a growing Digital Health Startup Company-

The Quality and Regulatory Affairs Associate will champion, support or lead quality improvement initiatives as well as strategizing, supervising and executing regulatory work for the Company. 

Responsible for ensuring the quality of products, processes and services of the Company in accordance with applicable regulatory requirements.

♦️ Prepares, submits and communicates submissions to regulatory agencies/authorities worldwide.

♦️ Prepares regulatory strategies/plans and worldwide compliance requirements. Provides on-going support to project teams for regulatory issues and questions.

♦️Translates regulations, requirements, and guidelines into company policy/procedures and trains personnel accordingly.

♦️Develop and monitor appropriate quality metrics for review by management including inputs into the management review process. 

♦️ Evaluates sources of processes to determine root causes and to implement appropriate corrective and preventive actions. Ensures effectiveness of corrective and preventive actions implemented.

♦️Develop and monitor an Effective Complaint Management System

♦️ Work to manage and facilitate local quality system assessments including, but not limited to internal and third party inspections.

♦️ Manages corrective and preventive action (CAPA) and change order (CO) processes.

♦️ Coordinates ongoing enhancement and harmonization of quality systems.

♦️ Participates in the development and implementation of clinical trials.

♦️ Internal and external audits including supplier approval and evaluation.

♦️ Supervises, guides and executes RA activities of the Company

♦️ Reviews sales and marketing materials for regulatory compliance

♦️ Maintains Regulatory Affairs product files to support compliance with regulatory

Requirements

♦️ 2 or more years of work experience including quality system experience in a medical device, pharmaceutical, aerospace, automotive or other highly regulated environment.

♦️ Previous experience with ISO/CE certification process 

♦️ Previous experience with US and international medical device regulations 

♦️ In-depth knowledge of the following preferred: ISO 13485, ISO 14971, EU Directives and CFR 21 Part 820.

♦️ Excellent Communications Skills both written and verbal.

♦️ Bachelor's Degree required

♦️ Master's Degree preferred