Regulatory Affairs Specialist

Role Overview

• 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))