Manager, Regulatory Affairs and Compliance

Summary:

Develops, implements, and maintains a comprehensive Quality & Regulatory Affairs system in accordance with regulatory requirements.  A 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 labeling, 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.

General Duties and Responsibilities:

• 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.  Reviews design history files to ensure all regulatory requirements are being met.
• Reviews and provides regulatory authorization for labeling, marketing literature, and protocols/ reports for compliance with regulatory requirements.
• Evaluates, investigates, documents and communicates with both the FDA and/or other regulatory authorities on all product recalls.  Writes all recall communications to the field and customers.  Documents and reconciles product inventory associated with recall.  Follows up with corrective action associated with recall issue.
• Allocated resources to ensure department priorities are realized and budget goals are met.
• Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required.
• Supports an effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures.
• Provides support for external audits conducted by Quest customers and regulatory authorities.
• Oversees document control efforts to ensure compliance with domestic and international regulations and standards.
• Contributes to the development and implementation of business operating plans.
• Evaluates and implement new document control systems.

Qualifications:

• 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.  Knowledge of Japanese, Australian, and Brazilian requirements strongly preferred. 
• Demonstrated knowledge of ISO 14971 and IEC 60601 preferred.
• Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
• Previous experience with FDA regulatory submissions and CE marking.
• Experience interacting with regulatory bodies, such as the FDA and Notified Body.
• Experience with the UL certification process preferred.
• Excellent prioritizing, organizational, and interpersonal skills.  Ability to handle multiple projects simultaneously. 
• Must possess technical writing, project management and fundamental problem-solving skills.
• Ability to review and provide critical feedback on design documentation. 
• 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.
• RAPS RAC (US) preferred. 
• ASQ certification as a Certified Quality Auditor (CQA) preferred.