Regulatory Affairs Manager

Manager, Regulatory Affairs

Manager, Regulatory Affairs Responsibilities:

• Use in-depth working knowledge and understanding of international medical device, biologics, and HCT/P regulations to assume major responsibility for supporting new product development in International regions
• Utilize advanced base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business; Read and interpret scientific and technical documents to determine regulatory implications and summarize for submission to regulatory agencies.
• Provide regulatory input to cross-functional teams in support of international submission.
• Evaluate regulatory issues by performing research to support the creation of a regulatory strategy for the assigned program; Maintain up to date knowledge of regulatory requirements, comment on draft regulatory guidance, and communicate changes in regulatory information, as needed. Implement regulatory strategies and revise technical documentation for existing and new regulatory submissions, with periodic supervision.
• Lead in the development of International regulatory strategies and verification and validation activities for assigned product submissions.
• Provide regulatory support to international with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators to support certificate maintenance and license renewals.
• Interact with Regulatory Body personnel, specifically Notified Bodies, with minimal supervision, as needed.
• Actively lead the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company's Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews.
• Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers) to support compliance with regulatory requirements.
• Serve as the RA lead and work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with products expanding into the Canadian, European, and International markets according to regulations established in that region.
• Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
• Work independently to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations for the International regions.
• Problem solving Apply company policies and procedures to resolve a variety of issues of increasing complexity; Provide solutions to a variety of problems of moderate to high complexity.
• Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization.
• Contribute to the authoring of SOPs and train key personnel as needed.
• Perform other duties as assigned.

Manager, Regulatory Affairs Background requirements:

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field.
• Minimum of 4-6 years related experience
• Experience in working effectively with cross-functional teams and provide regulatory input (e.g., manufacturing sites, new product development teams, marketing teams, quality teams).
• Experience working with Canada, EU and other International regions.
• Strong working knowledge of international medical device regulations including international dossier submissions; Experience with medical device, biologic or implantable products is preferred, but not required.
• Understanding and application of business strategies and tactics, including an understanding of regulatory impact.
• Ability to effectively interface with multiple company disciples and responds to complex questions related regulatory requirements.
• Must have proven ability to prepare and submit documents to regulatory agencies independently or with minimal supervision.
• Ability to explain regulatory requirements and pitfalls to project teams and colleagues.
• Able to effectively 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 European Medical Device Directive (MDD), Medical Device Regulations (MDR), and quality system requirements.
• Proven skills in the planning, coordination, and approval of CE registrations.
• Must have data analysis, technical writing, project management and communication skills.
• Demonstrated skills in contributing to multiple projects simultaneously.
• Established skill in objective and critical thinking.
• Develops proposals for solutions and applies solutions to identified issues.
• Develops plans to meet pre-defined Regulatory goals.
• Responsible for tasks and advanced submission components with ability to create templates when non exist.
• 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.