Integra LifeSciences · 1 day ago
Senior Specialist, Regulatory Affairs
US-MA-Braintree-220-Facility
Full-time
Onsite
Mid, Senior Level
$82K/yr - $113K/yr
3+ years expIntegra LifeSciences is a company focused on innovating new treatment pathways to advance patient outcomes in healthcare. The Senior Regulatory Affairs Specialist is responsible for implementing regulatory strategies and ensuring compliance with regulations globally, while providing regulatory input for documentation and product development.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Using a broad base of knowledge and understanding of regulatory requirements, will assume major responsibility for supporting new product development
Utilizing an advanced base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business
Provide regulatory input to cross-functional teams. Works independently to evaluate regulatory issues, develop and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions
Lead in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions. Author draft submissions (510k, PMA, BLA) with minimal supervision
Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Under minimal supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements
Interact with Regulatory Body personnel with minimal supervision. Actively lead the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews
Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements
Develop regulatory strategies around ad/promo reviews based on regulations; Review promotional and advertising material for adherence to approved product claims and regulatory compliance
Serve as the RA lead and work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations
Lead rollouts of product changes with corporate and international regulatory teams
Lead Unique Device Identification system requirements and other labeling compliance of new products introduced into the market. Plan and coordinate rollouts of product changes with corporate and international regulatory teams
Serve as RA lead and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions
Support product risk management in accordance with FDA/ISO 14971. Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations
Work independently to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations Problem solving: Apply company policies and procedures to resolve a variety of issues of increasing complexity; Provide solutions to a variety of problems of moderate to high complexity. Participate in and lead continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned
Contribute to the authoring of SOPs and train key personnel as needed. Perform other duties as assigned
Qualification
Required
Bachelor's degree in science, Engineering, Regulatory Affairs, or other technically related field
Minimum of 3-5 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 2 years in Regulatory Affairs and the remaining years can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met: RA Certification (RAC) can count towards 1 year of specific RA experience, Master's degree can count towards 2 years of relevant (non-RA) experience, Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience
Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams)
Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA Supplements,361 HCT/Ps, and international dossier submissions
Understanding and application of business strategies and tactics, including an understanding of regulatory impact
Ability to effectively interface with multiple company disciplines and responds to complex questions related regulatory requirements
Must have proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision
Ability to explain regulatory requirements and pitfalls to project teams and colleagues
Can communicate existing facts in an organized and clear manner to cross-functional teams
Must be detail oriented, well-organized, and able to work both independently and in teams
Must possess and demonstrate an understanding of FDA requirements and quality system requirements
Must have strong writing, project management and communication skills
Demonstrated skills in contributing to multiple projects simultaneously
Established skill in objective and critical thinking
Develops proposals for solutions and applies solutions to identified issues
Develops plans to meet pre-defined Regulatory goals
Responsible for tasks and advanced submission components with ability to create templates when none exist
Capability to interact with diplomacy and tact while maintaining appropriate assertiveness
Willingness to take ownership and accept responsibility for actions and decisions
Ability to communicate effectively in both informal and formal settings
Preferred
Experience with medical device, biologic or implantable products is preferred, but not required
Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
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