TELA Bio · 1 day ago
Sr Regulatory Affairs-Quality Specialist
Malvern, PA
Full-time
Hybrid
Mid, Senior Level
$80K/yr - $120K/yr
4+ years expTELA Bio is a company focused on continuous improvement in quality systems, and they are seeking a Senior Regulatory Affairs/Quality Specialist. This role involves leading regulatory submissions, developing regulatory strategies, and participating in compliance activities to ensure adherence to quality policies and systems.
BiotechnologyLife SciencePharmaceutical
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
Qualification
Required
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
Preferred
Certifications, such as RAC preferred
Company
TELA Bio
TELA Bio is a life science company that specializes in soft tissue reconstruction.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$349.45MKey Investors
EW Healthcare Partners,Nantahala Capital ManagementPerceptive AdvisorsMidCap Financial
2025-11-13Post Ipo Equity· $13M
2025-11-13Post Ipo Debt· $60M
2024-10-23Post Ipo Equity· $46M
Leadership Team
Antony Koblish
Co Founder and CEO
Greg Firestone
Chief Commercial Officer
Recent News
FierceBiotech
2025-12-26
2025-12-13
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