Sr Regulatory Affairs-Quality Specialist

Tela Bio Inc•Malvern, PA

19d•Hybrid

About The Position

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 TELA Bio organization, the individual is expected to establish and maintain a work environment of continuous improvement that supports the quality policy and overall quality system.

Requirements

Bachelor’s degree in scientific or engineering discipline
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
Must have demonstrated ability to multi-task in high pressure, changing conditions. Ability to carry and lift to 10 lbs.

Nice To Haves

Certifications, such as RAC preferred

Responsibilities

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
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 TELA Bio’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 TELA Bio CER procedure and Adverse Event reporting
Provide input regarding product recalls or advisory notices, CAPAs, investigations, and non-conformances
Maintain TELA Bio’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 TELA Bio QMS including but not limited to, review and revision of quality system procedures