Sr. Regulatory Affairs/Quality Specialist

Job Description

The Sr. Regulatory Affairs/Quality Specialist is responsible for leading and assisting with various regulatory submissions, authoring, and editing regulatory documentation and procedures, and participating in compliance activities. As a key member of the company’s organization, the individual is expected to establish and maintain a work environment of continuous improvement that supports the quality policy and overall quality system.

Essential Duties and Responsibilities

Pre-market regulatory/quality

• Participate as the regulatory or quality representative on product development teams
• Develop and implement regulatory strategies for new and modified products, including expanded indications and intended uses
• Provide feedback and guidance on technical documents required for regulatory submission
• Prepare and submit US and OUS regulatory applications, including but not limited to IDEs and supplements, 510(k)s, PMAs (including supplements, notices, and annual reports), EU Technical Documentation, EU notice of changes
• Document “no file” decisions for exempt products or modifications which do not require formal submission to a regulatory authority
• Review device labeling and promotional materials for compliance with global regulations

Post-market regulatory/quality

• Assess regulatory impact of post-market changes including changes in labeling, design, materials, manufacturing, sterilization and/or packaging
• Prepare and submit notice of changes to the company’s notified body and prepare and submit other EU periodic documentation such as PMS Reports, PSURs, SSCP updates etc.
• Communicate with manufacturing partners to respond to regulatory concerns/questions
• Manage the Customer Experience Reporting (CER) system, ensuring complaints are documented and investigated appropriately, and assessed for regulatory reporting within statutory timelines
• Conduct periodic sales training for newly hired employees on the company’s CER procedure and Adverse Event reporting
• Provide input regarding product recalls or advisory notices, CAPAs, investigations, and non-conformances
• Maintain company’s regulatory clearance matrix, GS1, and GUDID Database
• Author and publish regulatory memos to support other departments (Product Development, Sales, etc.), as necessary
• Conduct regulatory reporting for adverse events, field actions and/or recalls
• Participate in regulatory inspections
• Continuously improve the company’s QMS including but not limited to, review and revision of quality system procedures

Education and Experience

• Bachelor’s degree in scientific or engineering discipline
• Certifications, such as RAC preferred

Required Knowledge, Skills and Abilities

• At least 4 years combined Regulatory Affairs/Quality experience, medical device experience preferred
• Experience with complaint handling and adverse event reporting
• Knowledge of US and European/international regulations and standards, working knowledge of EU MDR
• Experience with authoring regulatory submissions
• Experience with interacting with regulatory agencies