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Regulatory Affairs Specialist

Sonic Incytes is seeking a full-time Regulatory Affairs Specialist, who is responsible for regulatory activities including regulatory submissions, annual reports, registrations, and listings. The Regulatory Affairs Specialist ensures compliance with applicable medical device regulations per jurisdiction, guidance, and standards, across all areas of the business. The Specialist leads the creation and maintenance of all Sonic Incytes regulatory files.

Key Responsibilities

  • Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
  • Maintain regulatory files and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
  • Lead the preparation of responses to regulatory authorities’ questions within assigned timelines.
  • Stay abreast of regulatory procedures and changes in regulatory climate.
  • Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
  • Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
  • Assist in the creation and maintenance of the Quality Management System (QMS).
  • Other duties as assigned.

Qualifications and Experience

  • Bachelor’s degree in Engineering or Science or a related scientific discipline. Higher degree/PhD will be an advantage.
  • RAPs certifications, preferred.
  • 3-5 years regulatory or equivalent experience within a device, pharmaceutical or life sciences company.
  • Scientific knowledge is essential, must be able to digest complex data while keeping the big picture through good analytical skills.
  • Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
  • Experience leading and/or assisting internal and external audits.
  • Proactive, high performance and result oriented, with the ability to manage projects with ethical integrity.
  • Comfortable working independently and leading the regulatory department and its processes.
  • Experience in software and manufacturing environments, including knowledge or relevant standards is an asset (e.g., ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 62366).
  • Experience in technical writing (e.g., creating product user manuals, report writing).
  • Technical system skills (e.g. MS office applications, databases, efficient online research).
  • Manage multiple projects and deadlines.
  • Ability to identify compliance risks and escalate when necessary.
  • Demonstrate both creative and critical thinking skills.

About Sonic Incytes

Sonic Incytes believes in creating accessible and affordable healthtech solutions – with health insights you can count on – to improve patient care.

Recognizing the rise of chronic liver disease, Sonic Incytes is on a mission to make liver health a new vital sign. Its novel, point of care ultrasound solution, Velacur™, is redefining the standard of care in quantifying liver tissue stiffness and attenuation to aid in the clinical management of patients with chronic liver disease.

To Apply

Are you wanting to have a positive impact and up for a new challenge? If yes, we want to hear from you!

To apply for this position, please send your cover letter, resume to Human Resources, hr@sonicincytes.com. Due to the high volume of applicants, only those selected for an interview will be contacted.

For more information about the company, please visit www.sonicincytes.com.

For more information about our solution, Velacur™, please visit https://www.velacur.com/