Medical Aesthetics Research and Development Leader

7 days ago

Richmond Hill, Ontario, Canada Brunel Full time
Senior Scientist

We are seeking a highly skilled Senior Scientist to join our Medical Aesthetics company in GTA. This is an exciting opportunity for a talented professional to contribute to the development of innovative medical devices and biomaterials.

The successful candidate will be responsible for leading research activities, including project conception, study design, resource management, scientific data review, and reporting. They will also be responsible for managing company intellectual property and collaborating with the Global Chief Scientific Officer to drive product development.

Key Responsibilities:

  • Drive the execution of technical development plans spanning preclinical animal studies through process validation to support IDE and PMA submission.
  • Initiate new projects for the R&D team to sustain the company's product pipeline.
  • Supervise project-related scientific/technical activities and contribute to strategic decision-making by reviewing and evaluating data, interpreting results, and drawing relevant conclusions.
  • Ensure technical readiness by designing, reviewing, and approving animal study protocols for commencing preclinical studies in support of IDE submission.
  • Provide technical expertise by authoring drug and medical device IDE and PMA modular components covering product background, device description, preclinical testing, product biocompatibility, manufacturing process, and product testing and characterization.
  • Partner with Quality/Regulatory and Analytical Technical experts to prepare Technical Files and Design Dossiers in line with different market requirements.
  • Assist the Global Chief Scientific Officer in evaluating key technologies of biotech companies and analyzing their technological capabilities for Merger & Acquisition activities.
  • Assist the Global Chief Scientific Officer in evaluating budgetary proposals from Contract Manufacturing Organizations to determine the optimum budget for product characterization and biocompatibility studies.
  • Participate in the R&D, Regulatory, and Clinical bi-weekly team meeting to prepare IDE and PMA submissions.
  • Communicate current scientific findings to the Global Chief Scientific Officer through peer-review journals, ISO standards, and clinical trials to assist in the company's product development pipeline.

Requirements:

  • PhD in Chemistry, Materials Science, or Polymer Science with 10-12 years of related industrial experience.
  • Strong knowledge of medical device development and approval (Class I, II, III) and Biologics.
  • Experience with combination devices or drug delivery applications.
  • Deep understanding of medical device and biologic manufacturing processes.
  • Late-phase development experience including process validation, authoring of IDE, PMA sections, technical files, and design dossiers.
  • Experience with cosmetic dermal fillers based on Hyaluronan and other biomaterials.
  • Strong knowledge of Regulatory Standards (ISO) and Regulatory Audits (Health Canada, FDA, EU).
  • Project Management Experience for developing a product through pre-clinical, clinical phase, and commercialization.

Estimated Salary: $120,000 - $180,000 per year, depending on experience and qualifications.

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