Regulatory Compliance Manager:
- This position is responsible for coordinating regulatory compliance, by understanding and adhering to ISO4971: 2019, ISO13485, ISO9001, and other standards for medical devices.
- This position is also responsible for establishing, implementing, and maintaining quality management procedures and systems for Curiato Inc. products.
Job Specific Responsibilities:
- Implementing quality management policies, procedures, and systems for all of Curiato Inc. products;
- Minimizing claims and complaints from customers by continually improving the Quality Assurance system;
- Receiving customer claims and complaints, finding and analyzing root causes with excellent communication skills
- Qualification, implementation, and maintenance of a document management system on Microsoft OneDrive
- Recommending corrective and preventative action for nonconforming products;
- Making periodic audit for procedures and systems to maintain the product’s quality internally and externally
- Ensuring the proper handling and disposing of products
- Managing decisions regarding irregular occurrences including accidents, legal violations, in coordination with department management.
- Monitoring and studying new and existing Health Canada and FDA regulations regarding medical devices
- Providing information about the development and changes of regulations that may affect business;
- Maintaining records of compliance
- Ability to maintain a high level of accuracy and attention to detail
- Effective project management skills
General Skills Language Skills
- Ability to read, analyze, and interpret general business periodicals, professional journals, and/or government regulations in English.
- Ability to write reports, business correspondence, and procedure manuals in English.
- Ability to effectively present information and respond to questions from groups of managers, staff, clients, customers, and the general public in English.
- Must be able to use a computer and such applications like Microsoft Windows, Word, and Excel.
- Experience with Smartsheets platform is a major advantage
- Bachelor’s degree; and four to ten years related experience and/or training; or equivalent combination of education and experience.
- Ideal candidates are experienced with interpreting quality guidelines, regulatory requirements and demonstrate strong technical abilities along with well-developed leadership skills.
- The candidate must have a working knowledge of quality management systems, manufacturing, regulatory compliance, internal/external auditing and the ability to engage and collaborate with stakeholders to drive improvements.