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About the role
- Regulatory Affairs Specialist implementing compliance strategies for Integra LifeSciences’ products. Collaborate with teams globally to ensure adherence to US and international regulations.
Responsibilities
- 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))
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