Regulatory Engineer (QS / Audit / 5 Days / Joo Koon)

  • Full time
  • Singapore
  • Closes : August 29, 2022
Company :
Sunningdale Tech Ltd
Responsibilities:
  • Ensure compliance of internal procedures with USFDA 21CFR Part 820, ISO 13485 and other regulatory and statutory requirements whichever is applicable to STL products
  • Work with Quality System engineer to ensure the implementation of quality system that is appropriate for medical device components / Medical Devices/ healthcare manufacturing, complies with FDA 21 CFR Part 820 , ISO 13485 and other applicable regulatory and statutory requirements
  • Ensure continued compliance to relevant regulatory and statutory requirements requirements (CE, FDA, HSA, Food Safety related).
  • Communicate and interact directly with all departments including R&D, Business Development, Manufacturing, Tooling, Planning, Shipping with regards to regulatory issues
  • Compilation of technical dossiers, technical files, regulatory submissions for target markets and per customers’ and organization’s requirements
  • Responsible for Product and establishment registration and maintenance.
  • Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures, ISO 13485 / FDA 21 CFR Part 820 regulations and requirements.
  • Provide applicable regulatory update on a regular basis
  • Work with purchaser for request with regards to updated regulation declaration / compliance letter from supplier to ensure used material comply to relevant customer, medical devices and food safety requirements.
  • Issue regulatory declaration / compliance letter to customers to ensure our product meets customer requirements.
  • Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives.

Requirements:
  • Min Diploma / Degree in Biomedical Engineering or equivalent
  • Sound knowledge in US FDA 21 CFR Part 820 Quality System Regulation, CE Mark, Quality System (e.g. ISO13485, ISO 9001, FSSC)
  • Proficient in MS Office
  • Team player, self motivated and able to follow datelines, leadership qualities
  • Possess knowledge of ISO Quality System Regulations and international Standards will be an added advantage

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Only shortlisted candidates will be notified

Sunningdale Tech is an equal opportunity employer – we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.

All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.

Career Level

Exempt

elaine.tua@sdaletech.com




I certify that the information provided, and the statements made in this application are true and correct. I accept that any false/inaccurate information /statement made by me in this application and/or any supplement thereto or in connection with the application will result in the immediate termination of my employment with the company.