Regulatory Affairs Manager

Job content

• Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers)
• Lead and mentor a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business.
• Manage the development of US and International regulatory strategies and verification and validation activities for assigned product submissions.
• Author submissions (510k, MDR files, MDD changes) independently. Ensure timeliness of regulatory submissions according to business needs.
• Actively lead and/or manage the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies.
• Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements.
• Develop regulatory strategies and internal processes around ad/promo reviews based on regulations; Provide expert guidance to teams and oversee review of promotional and advertising material for adherence to approved product claims and regulatory compliance.
• Manage RA leads as well as manage partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations.
• Manage rollouts of product changes with corporate and international regulatory teams.
• Manage the planning and coordination of rollouts of product changes with corporate and international regulatory teams.
• Provide oversight and 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.
• Manage the regulatory review of 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.
• Manage and establish labelling requirements per regulations and review labelling that requires regulatory review and approval to ensure compliance with government regulations
• Apply company policies and procedures to resolve a variety of issues of increasing complexity; Provide solutions to a variety of problems including those of a highly complex nature.
• Lead and participate in continuous improvement projects within Regulatory Affairs and throughout the organization.

• Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
• Minimum of 4 years in Regulatory Affairs working in an FDA regulated industry in the Medical Devices
• Strong experience in working effectively with cross-functional teams and provide regulatory input
• Experience working with FDA locally and nationally.
• Expert applied knowledge of domestic and/or international medical device regulations including 510k and international dossier submissions
• Strong applied understanding of business strategies and tactics, including an understanding of regulatory impact.
• Proven experience in effectively communicating and working with US FDA, European Notified Bodies, Competent Authorities, and other regulatory agencies.
• Proven skills in the planning, management, and approval of CE registrations and US 510(k)
• Must have strong data analysis, technical writing, project management and communication skills.
• Demonstrated skills handling multiple demanding projects and in contributing to multiple projects simultaneously.
• Develops proposals for solutions and applies solutions to identified issues.
• Develops plans to meet pre-defined Regulatory goals.
• Willingness to take ownership and accept responsibility for actions and decisions.