Regional Manager, Regulatory Affairs

2 weeks ago

Atlanta, United States Symmetrio Full time
Symmetrio is currently recruiting a qualified individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be responsible for overseeing the functions and team, for the North and South Americas Region, in alignment with the department's defined directions and initiatives. You will be responsible for the execution of global & local regulatory and quality strategies and policies as defined in the departmental business plan. The role involves setting priorities and expectations for direct reports, as well as monitoring and reporting on budget, planning, and logistics.

Responsibilities
  • Drive departmental activities in line with the overall mission and actively 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.
  • Demonstrate leadership through delivering results, aligning priorities, developing teams, and managing 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 changes in legislation, provide support and advice on regulatory strategies as impacted and work cross-functionally to implement changes.
  • 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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