Senior Engineer – Regulatory

  • Full time
  • Singapore
  • Closes : –
  • This position has been filled
Company :
Sunningdale Tech Ltd
Responsibilities:
  • Acts as company liaison with HSA and other Regulatory Agencies
  • Provide independent regulatory guidance to product development teams
  • Responsible on all Regulatory compliance issues with external and other compliance authorities
  • Ensure compliance to various international regulations including FDA510K to achieve Total Customer Satisfaction
  • Ensure process and product conformity with corporate specifications, government, and industry standards
  • Lead in medical device certification
  • Lead and advice on testing requirements for medical device
  • Drive customer complaints activities to closure with corrective and preventive action and ensure that all customer complaints are documented and updated timely
  • Work with the manufacturing sites to ensure that all the containment actions are carried out effectively and according to plan
  • Track effectiveness of containment actions
  • Establish limits and exceptions with customers and ensure that is documented and communicate with the operations team
  • Lead & conduct Process & Product Audit and follow up audit findings closure with respective department’s HODs
  • Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirements:
  • Bachelor’s degree in Science or Engineering or related discipline
  • 4 years relevant experience in medical device industries
  • Knowledge of healthcare products from application, product requirement, certification, compliance
  • Familiar with FDA and ISO13485 requirements
  • Familiar with biological or clinical evaluation of medical device
  • Experience in regulatory testing and submission for medical device
  • Evaluate medical product compliance

 

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

sgp.hr@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.