Integra LifeSciences

Regulatory Affairs Specialist

Integra LifeSciences

full-time

Posted on:

Location Type: Office

Location: Princeton • Massachusetts • New Jersey • United States

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Salary

💰 $71,300 - $97,750 per year

About the role

  • Implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally
  • Providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met
  • Analysis and review of data
  • Resolution of regulatory issues of moderate scope
  • Maintenance/update of existing technical files
  • Ensuring that new products are compliant to new requirements
  • Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support 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 mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions
  • Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions
  • Author draft submissions (including MDR Technical Documentation) under supervision
  • Ensure timeliness of regulatory submissions according to business needs
  • Includes ensuring prompt follow-up to the questions and requests received from regulators
  • 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
  • Begin to interact with Regulatory Body personnel under direct supervision
  • Actively assist with upcoming audits and certification reviews with all Company designated Notified Bodies
  • Support communication with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews
  • Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements
  • Review promotional and advertising material for adherence to approved product claims and regulatory compliance
  • Work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations
  • Coordinate rollouts of product changes with corporate and international regulatory teams
  • Coordinate Unique Device Identification system requirements and other labeling compliance of new products introduced into the market
  • 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 under supervision
  • Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations
  • Works under moderate supervision
  • Review labeling that requires regulatory review and approval to ensure compliance with government regulations
  • Apply company policies and procedures to resolve a variety of issues of moderate complexity; Provide solutions to a variety of problems of moderate scope and complexity
  • Participate in continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned
  • Contribute to the authoring of SOPs
  • Perform other duties as assigned

Requirements

  • Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field
  • Minimum of 2 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 1 year in Regulatory Affairs and the other year 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 (e.g., manufacturing sites, new product development teams, marketing teams, quality teams, external partners)
  • Experience with medical device, biologic or implantable products is preferred, but not required
  • Awareness of business strategies and tactics, including an understanding of regulatory impact
  • Must have proven ability to prepare and submit documents to regulatory agencies, with supervision
  • Ability to explain regulatory requirements and pitfalls to project teams, colleagues, and external partners.
  • 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, European Medical Device Directive (MDD), Medical Device Regulations (MDR), 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 thinking.
  • Brings proposals for solutions to identified issues.
  • Develops plans to meet pre-defined Regulatory goals.
  • Responsible for tasks and intermediate submission components, based on templates.
  • 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.
  • 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))
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiesregulatory documentationdata analysistechnical documentationregulatory submissionsFDA PMA filingsBLA filingsrisk managementChange Engineering RequestsQuality System Documentation
Soft Skills
communication skillsdetail orientedwell-organizedproject managementobjective thinkingproblem-solvingteam collaborationindependent workdiplomacyassertiveness
Certifications
Bachelor's degreeMaster's degreeDoctorate or PhDRegulatory Affairs Certification (RAC)