Regulatory Affairs Director

5 days ago

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

Job Title: Regulatory Affairs Director

Company: ICON plc

Location: EMEA

Job Type: Full-time

Industry: Healthcare, Medical Devices

About Us:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Summary:

We're seeking a highly experienced Regulatory Affairs Director to lead our regulatory strategy and ensure compliance with local and global medical device regulations. As a key member of our team, you will be responsible for developing and implementing regulatory strategies, managing workflow, and providing strategic advice to clients.

Key Responsibilities:

  • Develop and implement regulatory strategies for IDE/CTA/ITA submissions, Pre-Submission Requests, Breakthrough Designations, 513g Submissions, 510(k) Submissions, DeNovo Submissions, PMA submissions, and Scientific Validity Reports.
  • Manage workflow, including prioritizing project objectives and establishing timeframes for projects with clients and managing client contracts.
  • Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
  • Act as scientific thought leader for ICON and support initiatives to ensure ICON is at the leading edge of new regulatory developments.
  • Conceptualize and draft complete proposals based on a client idea or Request for Proposal (RFP), including independent development of project plans and scientific content for clients.
  • Function as primary liaison with regulatory agencies for designated projects and designated clients.

Requirements:

  • Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field.
  • 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:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits, including:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

How to Apply:

If you're a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application. We welcome applications from diverse candidates and are committed to creating an inclusive environment.

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