Regulatory Affairs Specialist

1 day ago

Uxbridge, United Kingdom Parexel Full time
Regulatory Affairs Consultant - Medical Device Regulatory Lead

We are seeking a highly skilled Regulatory Affairs Consultant to lead our medical device regulatory efforts. As a key member of our team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.

Key Responsibilities:
  • Develop and implement innovative medical device regulatory strategies for combination products and delivery systems.
  • Provide regulatory guidance and advice to development teams, ensuring compliance with global regulatory requirements.
  • Prepare and review regulatory design control deliverables, ensuring accuracy and completeness.
  • Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions.
  • Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes.
  • Identify and manage issues and opportunities that impact submissions timelines, ensuring timely communication and resolution.
  • Ensure regulatory plans are monitored, progress/variance communicated to Management, and risks are highlighted.
  • Lead and/or support device-related health authority interactions, ensuring effective communication and resolution.
  • Provide regulatory impact assessments for proposed product changes, ensuring alignment with company goals.
  • Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
  • Contribute to internal regulatory processes and procedures for medical devices and combination products.
  • Engage with regulatory bodies and industry groups to influence industry standards and regulations, ensuring the company's best interests are represented.
Requirements:
  • University degree in a scientific or engineering discipline.
  • At least 5 years of relevant medical device and/or combination product regulatory experience required.
  • Solid understanding of global regulatory requirements for combination products and drug delivery systems.
  • Working knowledge of technical/industry standards related to drug delivery systems.
  • Proven experience in drug/device combination product regulatory approvals.
  • Demonstrate strategic thinking, initiative, change agent leadership, and risk assessment proficiency.
  • Ability to synthesize and critically analyze data from multiple sources.
  • Strong interpersonal skills and the ability to deal effectively with various business areas.
  • Demonstrate excellent communication and influencing skills, both written and verbal, in English.

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