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The Regulatory Affairs Specialist is responsible for implementing regulatory strategies for the Company with a focus on achieving compliance with all current and upcoming regulations in the US and EU. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Responsibilities include analysis and review of data, resolution of regulatory issues of moderate scope, creation and maintenance/update of existing technical files and ensuring that products are compliant to new and updated requirements.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• 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 create and revise technical documentation for existing and new regulatory submissions.

• Prepare regulatory strategies under supervision. Author draft submissions and response to questions under 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 supervision, assist with the coordination, preparation, and maintenance of FDA 510(k) filings 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.

• Maintain Regulatory Affairs product files (e.g. EU Technical Documentation) to support compliance with regulatory requirements.

• Under supervision, 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 and EU directives regulations.

• Coordinate rollouts of product changes with corporate and international regulatory teams.

• Coordinate with Regulatory Operations for updates to the Unique Device Identification system and to the FDA registration and device listing system.

• Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with directives and regulations.

• Works under moderate supervision.

• Review labeling that requires regulatory review and approval to ensure compliance with directives and regulations.

• Problem solving: 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.

QUALIFICATIONS

• 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.

• Experience in working effectively with cross-functional teams (e.g., manufacturing sites, new product development teams, marketing teams, quality teams).

• 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 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 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.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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