Senior Director of Regulatory Affairs

5 days ago

New York, United States Hobson Prior Full time

Hobson Prior is seeking a motivated Senior Regulatory Affairs Specialist focused on device development. The successful candidate will ensure regulatory compliance and support the development and commercialization of innovative medical devices. This role requires a strong understanding of regulatory requirements and experience in device development within the biotechnology or pharmaceutical industry.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Develop and implement regulatory strategies for medical devices.
  • Prepare and submit regulatory documents to authorities.
  • Provide regulatory guidance to teams throughout product development.
  • Monitor and interpret regulatory requirements to ensure compliance.
  • Communicate with regulatory agencies to facilitate product approvals.
  • Conduct risk assessments and develop strategies to address challenges.
  • Review and approve labelling and promotional materials for compliance.
  • Stay updated on industry trends and regulatory changes.

Key Skills and Requirements:

  • Degree in a scientific discipline.
  • Experience in regulatory affairs, focusing on medical device development.
  • Knowledge of global regulatory requirements for medical devices.
  • Experience in preparing and submitting regulatory documents.
  • Strong analytical and problem-solving skills.
  • Excellent communication and teamwork abilities.
  • Detail-oriented and organized, able to manage multiple projects.

For more information, please contact Henry LeLacheur.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.

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