Soundbite Medical Solutions logo

Soundbite Medical Solutions

Regulatory Affairs Professional

Regulatory Affairs – Saint-Laurent, Quebec
Department Regulatory Affairs
Employment Type Full-Time
Minimum Experience Experienced

SoundBite Medical Solutions Inc. is developing proprietary shockwave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.

We are currently seeking a Regulatory Affairs Professional to join our team based in the Montreal Office. 

In this role, your responsibilities will include:

Regulatory Advisory Responsibilities

  • Identify regulatory strategies and business decisions needed for timely approvals by regulatory bodies
  • Generate regulatory packages and component materials required for submissions, formal meetings, renewals, annual registrations and fee payments
  • Create and/or critically review documentation for quality audits and regulatory inspections
  • Support and coordinate preparation of meetings with the authorities
  • Keep abreast of, and communicate changes in, regulations, guidelines and regulatory requirements
  • Develop procedures to streamline company regulatory processes
  • Develop and communicate company guidelines to optimize organization and content of regulatory documents

 Compliance Responsibilities

  • Critically review study reports, protocols, procedures, specifications, release criteria, risk analysis and business documents (e.g., vendor contracts, business plans) to ensure compliance with SOPs, regulations and guidelines
  • Serve as regulatory reviewer of regulatory and scientific documents

  Therapeutic Knowledge Development

  • Maintain regulatory, scientific and clinical knowledge to achieve and optimize business strategies

 Professional Development

  • Develop and execute a personal professional development plan to enhance performance on the job

 Qualifications

  •  Minimum of 2 years’ experience in Regulatory Affairs;
  • Medical Device experience is considered an asset;
  • Experience dealing with Health Canada, the US FDA or European regulatory bodies;
  • Experience with regulatory applications;
  • Experience with any of the following regulations and related guidelines and policies: US Code of Federal Regulations (CFR), Canadian Medical Device Regulations (MDR), Canadian Food and Drug Regulations, European Medical Device Directives /Regulations (MDD/MDR);
  • Excellent organizational skills, ability to work independently as well as in Teams and manage competing demands;
  • Excellent verbal and written communication skills in English;
  • Critical thinking and analytical skills;
  • Experience with electronic submissions and/or filing;
  • Verbal and written communication skills in French, a definite asset;
  • Experience in any of the following fields is an asset: medical device risk analysis, human factors evaluation, clinical research, process training;
  • Strong interpersonal skills (ability to foster teamwork that ensures compliance).

Education Requirements

  • University Degree in a scientific field (B.Sc., M.Sc. or Ph.D.)
  • RAC Certification considered an asset
Thank You
Your application was submitted successfully.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Apply for this Job
  • Location
    Saint-Laurent, Quebec
  • Department
    Regulatory Affairs
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
  • Powered by