Regulatory Expert

1 week ago

Dublin, Dublin City, Ireland beBeeExpert Full time €80,000 - €100,000

Job Title: Regulatory Expert

This position involves overseeing post-market activities for medical devices and combination products. You will support departmental regulatory processes, develop strategies, author and review global registrations.

Responsibilities include ensuring timely and high-quality execution of all regulatory deliverables, mentoring team members, and ensuring compliance with relevant regulations.

Key skills and qualifications:

  • Experience in regulatory affairs for medical devices, preferably in the EU or US market
  • Strong knowledge of EU MDR, EU MDD, ISO 13485, and US FDA regulations
  • Excellent decision-making, communication, and technical writing skills
  • Ability to work independently, manage multiple priorities, and triage tasks in a fast-paced environment

Benefits:

Professional Growth and Development:

You will have opportunities for lifelong learning, growth, and development within our organization.

Competitive Compensation and Benefits Package:

Our compensation and benefits package is designed to reward your hard work and dedication.

Diverse and Inclusive Work Environment:

We strive to create an inclusive and diverse work environment where everyone feels valued and respected.

Opportunities for Advancement:

As you grow and develop in your role, you may have opportunities to take on additional responsibilities and advance within the organization.

Additional requirements:

  • Ability to comprehend principles of math, science, engineering, and medical device use
  • Ability to handle confidential information
  • Ability to research, read, analyze, and interpret complex data and documents
  • Ability to assess, plan, schedule, and manage multiple projects and priorities
  • Ability to communicate effectively with team members and management

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