Sr Regulatory Affairs-Quality Specialist
Position Title: Sr. Regulatory Affairs/Quality Specialist - RA/QA
Position Overview
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.
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 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
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
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to:
• Must have demonstrated ability to multi-task in high pressure, changing conditions. Ability to carry and lift to 10 lbs.
Working Conditions
This position works in a corporate office or home office. The noise level in the work environment is quiet to moderate.
Primary Location and Travel
• Ability to travel up to 10%
• We anticipate that on an ongoing basis this role will be a hybrid-based position although employee will be required in office for certain meetings/events (e.g. Management Review, leadership update meetings, audits, etc.).
Disclaimers
This is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.
TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website: www.telabio.com
Apply Now
Apply Now
Position Overview
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.
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 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
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
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to:
• Must have demonstrated ability to multi-task in high pressure, changing conditions. Ability to carry and lift to 10 lbs.
Working Conditions
This position works in a corporate office or home office. The noise level in the work environment is quiet to moderate.
Primary Location and Travel
• Ability to travel up to 10%
• We anticipate that on an ongoing basis this role will be a hybrid-based position although employee will be required in office for certain meetings/events (e.g. Management Review, leadership update meetings, audits, etc.).
Disclaimers
This is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.
TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website: www.telabio.com
Apply Now
Apply Now