Focal Healthcare Inc. designs, manufactures and commercializes leading-edge medical devices for improved prostate cancer diagnosis and management.
Reporting to the Chief Executive Officer, the holder of this position will be responsible for developing and heading the execution of global regulatory and quality system strategies. Strategies will be developed with an emphasis on finding viable options that ensure human safety and compliance while helping to achieve company business objectives.
Oversee all regulatory, clinical and quality related activities within Focal Healthcare Inc.
Maintain and improve Focal Healthcare’s quality system
Direct all Regulatory Affairs activities
Ensure all products designed, manufactured and shipped meet all regulatory, corporate and customer requirements for quality, safety, and efficacy
Direct development of Design History File and project management of quality related activities in development projects
Review batch records and release of products
Lead the development and execution of global regulatory strategies, submissions, and interactions with regulatory bodies and agencies
Oversee change control, CAPA, and customer complaint handling processes
Gather, analyze, document and communicate key risks to executive management and recommend ways to control or reduce the risk
Conduct supplier, contract manufacturer, and internal audits
Maintain up-to-date knowledge and monitor changes in pertinent laws, regulations, guidances, and other quality assurance and regulatory issues
Create and promote quality initiatives to ensure compliance within Focal Healthcare
Oversee regular employee training in ISO 13485, FDA QS Regulations, and any new regulatory developments
Hire, train, mentor, and manage regulatory affairs/quality team members.
Fundamental understanding of the medical device development process, including related practices and procedures for both software and mechanical devices.
Working knowledge of ISO 13485, IEC 60601, IEC 62304 and ISO 14971 as they relate to medical devices, FDA Quality System Regulations practices and procedures, Health Canada Medical Devices Regulations/CMDCAS, and EU MDD.
Working knowledge of the Good Manufacturing Practices and applicable regulations and guidelines.
Experience in the medical device manufacturing industry preferred.
Able to prioritize and manage multiple tasks simultaneously.
Good organizational and project management skills.
Good business acumen.
Excellent ability to identify and assess risks and come up with solutions to meet compliance requirements and business objectives.
Strong oral, written, negotiation, and interpersonal communication skills.
Ability to empower individuals and facilitate collaboration throughout the organization.
Excellent analytical and problem-solving ability.
Proven ability to work as a member of a team and independently; able to build strong and positive working relationships with cross-functional teams.
Education and Experience
A minimum of a Bachelor’s degree in a scientific or engineering discipline is A Master’s or Doctorate degree preferred. RAC certification preferred but not required.
3+ years of QA/RA experience within the Medical Device industry. Experience with both medical device manufacturing and international regulatory filings preferred but not required. Job title will be commensurate with experience.
Experienced in managing teams and complex projects.
Focal Healthcare requires that all employees are authorized to work in Canada. In the event an applicant does not have current work authorization, Focal Healthcare will determine, in its sole discretion, whether to sponsor an individual for work authorization.
Focal Healthcare is committed to accessibility and accommodation for persons with disabilities and will provide all appropriate accommodation upon request.
Focal Healthcare develops state-of-the-art prostate imaging and biopsy equipment to read and segment prostate MRIs and guide biopsy needles to a region of interest in real time by fusing MRI with live ultrasound.