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Regulatory Affairs Director

2 months ago

Reading, Reading, United Kingdom Icon plc Full time
Job Description

Job Title: Regulatory Affairs Director

Job Summary:

At Icon plc, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies for our clients in the medical device industry.

Key Responsibilities:

  • Develop and implement regulatory strategies for medical device clients
  • Act as a scientific thought leader for Icon and provide strategic advice to clients
  • Manage workflow, prioritize project objectives, and establish timeframes for projects
  • Develop and implement strategies and regulatory submissions for various medical device submissions
  • Function as primary liaison with regulatory agencies for designated projects and clients
  • Conceptualize and draft complete proposals based on client ideas or RFPs
  • Act as a scientific thought partner with clients and project teams throughout the project

Requirements:

  • Thorough working knowledge of local and global medical device Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
  • Effective project management skills
  • Strong computer skills, including Microsoft Office Suite and Adobe Acrobat
  • Excellent planning, organization, interpersonal, time, and change management skills
  • Knowledge of business development process
  • Uses appropriate regulatory, medical, and scientific nomenclature

Education:

  • Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field
  • PhD., D, MBA) in the biological, medical, chemical or engineering field is an asset

Experience:

  • Expert level experience in Regulatory Affairs knowledge within the setting of a Medical Device, CRO or Independent
  • Proven experience and effectiveness leading strategic regulatory activities for product development from entry into man through lifecycle management

What We Offer:

  • Competitive salary
  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme
  • Life assurance
  • Flexible country-specific optional benefits