Regulatory Affairs Specialist

Industry:

Company: Katalyst HealthCares and Life Sciences

Responsibilities:

• Develops, implements, and maintains a comprehensive Quality & Regulatory Affairs system in accordance with regulatory requirements
• highly participative leader, responsible for the hands-on management and direction of regulatory and document control personnel and for implementing best practices, continuous improvement, and corrective/preventive actions as necessary.
• Provides regulatory guidance to multifunctional teams on strategic planning to support compliance with all applicable domestic and international medical device regulations.
• The individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and Technical Files.
• Ensures conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials, and post-market feedback.
• Develops and implements organizational policies, plans and procedures to ensure best practices for Regulatory Affairs and Document Control.
• Establishes and monitors systems to maintain documents and records.
• Manages the personnel activities of the Regulatory Affairs and Document Control departments, including recommendations related to resource needs, training, and personnel development.
• Provides feedback on staff performance via performance reviews, and mentorship to continually improve staff skills and effectiveness.
• Reviews and assesses changes to global regulatory requirements and industry best practices, and facilitates implementation through new or revised Quality Systems processes.
• Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
• Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
• Provides technical guidance and instruction to staff in relation to regulatory affairs and document control policies and procedures.
• Evaluates and documents all alleged reportable events and field action reviews/assessments.
• Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes.
• Follows-up, as required, for failure investigations associated with reportable events.
• Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
• Maintains and prepares device registrations, listings, certifications, export certificates, and Declarations of Conformity.
• Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, Canadian, Australian, Japanese, and Brazilian requirements.
• Acts as a Regulatory Affairs representative on core product development teams.
• Communicates regulatory requirements and impact of regulations to the development teams.

Requirements:

• Bachelor of Science degree in a relevant discipline required.
• Minimum ten years of experience in medical device Regulatory Affairs, seven years in medical device Class II/III required.
• Candidates with 5+ years of practical experience in the regulated medical device industry may be considered if they possess an advanced degree in Regulatory Affairs or other related discipline.
• Minimum 5 years of experience with project management.
• Expertise in FDA QSR, ISO13485, EU MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements.
• Ability to handle multiple projects simultaneously.
• Must possess technical writing, project management and fundamental problem-solving skills.
• Excellent writing and communication skills.
• The individual should be detail-oriented and have good deductive and problem-solving skills.
• Due to the requirements of a quality assurance environment, a certain degree of initiative and good mechanical aptitude would be advantageous.