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The Regulatory Affairs Specialist is an intermediate level role responsible for 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.   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, maintenance/update of existing technical files and ensuring that new products are compliant to new 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 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 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 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.

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:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

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).

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 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.

Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job.