Prostate health careers at Focal Healthcare

Our Team is Growing!

 

We are looking for dynamic and driven individuals with experience in sales, marketing, software development and application/support to join our team and help improve the state of prostate care.

We care about our employees.

Our success depends on our team. At Focal Healthcare, you will be given the training and support you need to excel in your position and in your field. We work in a casual environment with flexible working hours. We also provide full healthcare and lunch benefits.

Great collaborative office environment.

With its brick walls, natural lighting, high ceilings, and open space, our office feels anything but corporate. All team members work in close proximity to encourage collaboration and innovation. Lunches are provided and eaten as a team with employees alternating cooking responsibility.

 Apply if:

  • You are passionate about making a difference- literally, not figuratively. All of our products have one thing in common: change the status quo to save lives.
  • You are hungry and humble and always enthusiastic to learn new things.
  • You believe it’s not over until you get it done. Your passion should come with a determination to follow through. You should be responsible and you must be reliable.

If this sounds like you, we would love to hear from you: careers@focalhealthcare.com

Current opportunities at Focal Healthcare:


 

Regulatory Affairs and Quality Assurance Associate

Reporting to the Director of Regulatory Affairs and Quality, the holder of this position will be responsible for supporting the execution of global regulatory and quality system strategies. Strategies will be developed with an emphasis on finding viable options that ensure both human safety and compliance and help achieve company business objectives.

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Responsibilities

  • Support the implementation and maintenance of a Quality Management System (QMS) in compliance with ISO 13485 standard, FDA Quality System Regulation (QSR), Canadian Medical Devices Conformity Assessment System (CMDCAS), and additional regional regulatory requirements, as applicable.
  • Maintain QMS document control and records maintenance system, including but not limited to Quality Manual, supplier files, Design History Files, Device Master Records, Device History Records, and distribution records.
  • Review regulatory, quality and manufacturing documentation, and support investigation of quality related issues.
  • Manage staff training program and support implementation of company policies and procedures.
  • Support internal and third party quality systems inspections and audits.
  • Support development of Design History Files and project management of new development projects relating to ensuring compliance with design control requirements, as assigned.
  • Support development of global regulatory strategies and submissions, and maintenance of medical device licenses and registrations.
  • Identify opportunities for and support implementation of process improvements.
  • Stay abreast of changing global regulations and standards.
  • Strengthen regulatory awareness and facilitate a quality culture within the company.

Required Skills

  • Excellent technical writing and presentation skills.
  • Strong knowledge of FDA QSR, ISO 13485, European Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), and the Canadian Medical Device Conformity Assessment System (CMDCAS).
  • Excellent knowledge and experience with Microsoft Office applications.
  • Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
  • Ability to work under pressure to meet deadlines.
  • Strong interpersonal and teamwork skills.

Education and Experience

  • Minimum 2 years of medical device experience; university degree in a life science related field or equivalent combination of education and experience.
  • Formal education and training in Quality Assurance/Regulatory Affairs is highly desired.

Focal Healthcare requires that all employees have authorization 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.

To apply, please send your resume to careers@focalhealthcare.com.

 

Lead – Regulatory Affairs and Quality

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.

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Responsibilities

  • 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.

Required Skills

  • 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 required. 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 have authorization 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.

To apply, please send your resume to careers@focalhealthcare.com.