Regional Manager Regulatory Affairs

3 days ago

Atlanta, Georgia, United States Symmetrio Full time
Job Overview

Symmetrio is seeking a seasoned professional to fill the role of Regional Manager Regulatory Affairs & Quality Americas. This position will oversee the functions and team for the North and South Americas Region, aligning with the department's defined directions and initiatives.

Key Responsibilities
  • Drive departmental activities in line with the overall mission and contribute to defining the vision for the department.
  • Collaborate with partner organizations and managers to set organizational goals.
  • Define the direction for changes needed to maintain and improve processes and work quality.
  • Lead teams and manage change for processes and procedures for regulatory and quality systems.
  • Act as the Regional Coordinator for regulatory submissions and regulatory strategies in the Americas.
  • Remain diligent about changes in legislation and provide support and advice on regulatory strategies as impacted.
  • Support, create, and maintain the Regional Submission Process(s) and Regulatory Roadmap.
  • Manage and coordinate the Regional Submission to regulatory authorities.
  • Represent the Company in the region in interactions with international bodies related to regulatory submissions.
  • Participate in and report to management reviews regarding all regulatory submissions and quality systems.
  • Support regulatory and quality staff in their interactions with national authorities and in the preparation of submissions and compliance data.
  • Deploy and implement Company Quality Policy and other directives and processes applicable to the region.
  • Manage departmental budgets as applicable.
Requirements
  • Bachelor's Degree in an engineering-related subject is preferred.
  • 3-5 years of knowledge and experience with a proven track record in Regulatory Affairs and Quality.
  • Knowledge in Supplier Quality, Quality, or Manufacturing Engineering, preferably in a medical device environment.
  • Knowledge of the European Directive for Medical Devices and US FDA regulations is an advantage.
  • Preferably an experienced ISO Auditor.
  • Experience with interpreting medical device product regulations and translating them into meaningful business requirements.
  • Capable of managing successful teams to deliver desired results.
  • Objective-driven and customer-focused, with the ability to influence people.
  • Structured approach to problem-solving with an appreciation of quality tools and techniques.
  • Effective team player with mentoring and leadership skills in problem-solving.
  • Confident and open personality with effective communication skills, both written and oral.
  • Positive attitude towards change to promote the global goals of the business.
Benefits
  • Health Care Plan (Medical, Dental & Vision)
  • 401k Retirement Plan (4% match)
  • Paid Time Off (Vacation, Sick & Public Holidays)

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