Medical Device Regulatory Affairs Manager

The right candidate for our Medical Device Regulatory Affairs Manager position will be responsible for championing all efforts to have the Medical Device Personnel to ISO-13485 standards.  The right individual will need to manage both internal and external expectations, adjust to changing priorities/environments while meeting deadlines, and have strong problem solving abilities. They will exhibit strong organization, facilitation, and communication skills, as well as work well in a fast paced environment.

Job Description:

  • Deploy and train all Medical Device Personnel to ISO-13485 standards to compliance for initial audit by a Notified Body
  • Lead ongoing development/implementation of processes and practices to ensure continuous compliance with ISO-13485, and relevant QMS requirements of the Therapeutic Goods Administration (TGA), ISO, Health Canada, and the National Health Surveillance Agency (ANVISA)
  • Coordinate required clinical evaluations and preparation of associated Clinical Evaluation Reports (CERs) required for Medical device filing
  • Act as project lead during preparation, submission and communication with FDA or other regulatory bodies such as the Therapeutic Goods Administration (TGA), ISO, Health Canada, and the National Health Surveillance Agency (ANVISA)
  • Perform CAPA route cause analysis and documents CAPAs
  • Provide regulatory intelligence regarding industry practices and develop regulatory strategies for national and international use
  • Liaison with regulatory bodies, including the FDA, and internal stakeholders on new medical devices from idea to device submissions
  • Perform internal audits to ensure compliance and serve as the lead during any regulatory audits (ISO-13485, etc.)

Core Requirements:

  • Bachelor’s degree in science or health related field and a minimum of 2 years’ experience in regulatory
  • Minimum 4 years’ demonstrated experience working in medical device industry
  • Exposure/experience with ISO 13485 and other international standards and country/region-specific medical directives (e.g., TGA, Health Canada, and ANVISA)
  • Knowledge of Process Development and the Software Development Lifecycle
  • Extensive knowledge of FDA 21 CFR Part 820 and other applicable FDA Regulations
  • Demonstrated experience in 21 CFR Part 11 regulated software

Desired:

  • Photography knowledge is advantageous
  • Excellent self-motivation skills

Founded in 1987, Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation.  Canfield has supported over 2,000 clinical studies, worked worldwide with thousands of clinical study sites, and has been retained by many of the world's leading biotechnology and pharmaceutical companies.  Canfield's imaging equipment leads the industry providing high-quality, registered, reproducible clinical images.  This, together with proactive clinical image monitoring and a world class quality assurance regimen, sets the gold standard in image quality for clinical studies.

Apply Here

Please submit resumes with cover letter, salary history, and salary requirements in confidence to jobs@canfieldsci.com for immediate consideration. Please include the position title in the subject line.

We are proud to be an equal opportunity employer.