About the Company
Our client is a global medical technology business that supports healthcare professionals in more than 100 countries, delivering affordable and accessible advanced medical technologies that help healthcare professionals improve the quality of life for their patients. This is a contract position through March.
The Regulatory Compliance Specialist effectively supports the complaint handling process, and processes complaints with a focus on Intake, MDR & Vigilance reporting in a uniform and timely manner. Key responsibilities include but are not limited to:
- Providing support for collection of data for medical and product investigation teams.
- Processing incoming product complaints and adverse events integral to the design, manufacture, delivery and service of our products in a uniform and timely manner.
- Processing or Receiving/Recording/Reviewing complaint information.
- Ensuring the accuracy and completeness of initial information from the Complaint Intake Forms or other complaint notification communications.
- Entering/Updating complaint information into complaint management software.
- Initial determination if a product issue is considered a valid complaint based upon company's definition.
- Interacting with and communicating with internal and external customers while meeting the challenges of regulatory compliance and its required documentation.
- Coordinating the return of affected products for assessment
- Preparing responses to standard and extended requests from Competent Authorities.
- Identifying and investigating solutions to procedure and process related issues.
Share This Position:
- Regulatory Reporting Experience for FDA MDR 3500A form
- 2-3 years Product Complaint Handling experience in medical devices OR 2-3 years Medical Device Reporting/OUS Adverse Event Reporting experience in medical devices
- Bachelor’s degree in biology, health sciences, engineering, nursing, law or other related discipline or equivalent relevant experience a plus.
- Regulatory knowledge with complaint handling; adverse event reports; recalls and quality systems.
- Strong critical thinking, communication, and problem solving skills
- Must have knowledge of U.S. Food and Drug Administration, European Medical Device Directive (MDD) and International Medical Device Regulations and quality system regulations (including 21 CFR 803 & 820, 93/42/EEC, and ISO 13485 / 14971
- Must possess excellent verbal and written communication skills
- Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.