Director of Regulatory Affairs

Our client is a market leader within Medical-Aesthetics Capital Equipment, that has pioneered within the industry over 25 years. Due to the fact that this establishment is fast-growing, a new opportunity has arisen and we at Consult are now recruiting for potential candidates to join the team. Within this particular role the successful candidate would be responsible for the collaboration, design and implementation of the worldwide regulatory strategy for all products.

• Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of information to prepare regulatory documentation packages for review and submission to regulatory agencies, subsidiaries or commercial partners.
• Plans, prepares, and manages timelines for assigned regulatory tasks including, but not limited to initial submissions, meeting requests, protocol assistance, etc., ensuring that timings are supportive of the corporate goals
• Leads the effort to support new product development and provide submission requirements for gaining market approval in the US and worldwide as necessary.as part of the design controls process. Supports the development and assessment of regulatory requirements for clinical and preclinical programs to assure all development activities are in compliance with applicable regulations and guidelines
• Reviews document and product changes for regulatory submission impact and carries out necessary change notification submission requirements as required.
• Reviews labeling, promotional materials and training materials for regulatory compliance.
• Maintains State Licenses, Registrations and other certifications as required to maintain regulatory and product approval compliance. Manages the compilation materials for license renewals, updates and registrations.
• Understands and communicates US and OUS regulation requirements. Actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates information to management.
• Provides regulatory review of documentation prior to submission for any external agency or customer, as required
• Interfaces with regulatory agencies as appropriate.
• Responsible for review of customer complaints for reportability to regulatory authorities and reporting to FDA and other regulatory agencies, as appropriate
• Oversees correction and removal activities
• Participates in development of Regulatory Strategy documents for new/improved products as required.
• Participates on project teams or sub-teams for the planning of activities needed to meet long term corporate objectives
• Maintains RA library, Submissions, Changes and documentation in hard copy and electronic files. Creates and maintains a calendar of regulatory applications and renewal dates.
• Provides supervision to reporting regulatory professionals including assignment of tasks and deadlines, performance appraisals and professional development

• Bachelor’s degree required
• Master’s degree preferred
• 12+ years of relevant experience in the medical device industry and direct regulatory experience
• Requires experience with complex regulatory submissions for medical devices
• Regulatory experience with active devices within software is strongly preferred
• Experience with international device regulations required
• Requires initiative, creative, problem-solving ability and superior oral and written presentation skills
• Demonstrated project management experience
• Regulatory Affairs Certification preferred.
• Ability to develop and maintain positive relationships with domestic and international contacts working in regulatory capacities within the government and other organizations.
• Demonstrated successful experience in registering medical devices within the US and internationally
• Managing Regulatory Affairs function within the medical device industry.