Manager Regulatory Compliance

Curiato Unverified

Lahore , Pakistan

Posted Mar 19, 2020 121 views Report Job

PKR. 40,000 - 70,000/Month

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Job Description

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.

Other Skills

  • Must be able to use a computer and such applications like Microsoft Windows, Word, and Excel.
  • Experience with Smartsheets platform is a major advantage

Experience/Education

  • 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.

Job Details

Industry:
Functional Area:
Total Positions:
1 Post
Job Shift:
First Shift (Day)
Job Type:
Job Location:
Gender:
No Preference
Minimum Education:
Bachelors
Degree Title:
Project Management / Business Administration / Finance
Career Level:
Experienced Professional
Minimum Experience:
3 Years
Apply Before:
Apr 19, 2020
Posting Date:
Mar 19, 2020
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Curiato

Engineering · 11-50 employees - Lahore

Curiato is a leading digital health company that is developing a continuous smart cover monitoring platform for healthcare facilities.