Global Quality & Regulatory Manager, Medical Devices

SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A global technology company in Singapore is seeking an experienced professional to develop and implement strategies for their medical division. The ideal candidate will have at least 7 years in Quality/Regulatory environments, expert knowledge of FDA regulations, and exceptional communication skills. Responsibilities include liaising with regulatory agencies, reviewing technical reports, and ensuring compliance with quality initiatives. A Bachelor's Degree in a scientific discipline is required, and the candidate must be willing to travel globally.

Qualifications

• Minimum 7 years of experience in a Quality/Regulatory and manufacturing environment.
• Experience with device submissions (510K, PMA, IDE) is a plus.
• Demonstrated professionalism in all working environments.

Responsibilities

• Develop and implement strategies for the medical division.
• Work with facilities on compliance with quality and regulatory initiatives.
• Liaise with FDA and regulatory agencies.
• Review technical reports for regulatory adherence.
• Recommend regulatory policies for FDA compliance.
• Modify and implement quality and regulatory practices.
• Schedule and track project activities for the division.
• Stay updated on laws and regulations relevant to projects.
• Provide input on regulatory strategies.
• Prepare and review Standard Operating Procedures.

Skills

Expert knowledge of FDA regulations

Strong written and verbal communication skills

Proficient use of MS Office Software Package

Ability to travel globally

Education

Bachelor's Degree in a scientific discipline

Job description

A global technology company in Singapore is seeking an experienced professional to develop and implement strategies for their medical division. The ideal candidate will have at least 7 years in Quality/Regulatory environments, expert knowledge of FDA regulations, and exceptional communication skills. Responsibilities include liaising with regulatory agencies, reviewing technical reports, and ensuring compliance with quality initiatives. A Bachelor's Degree in a scientific discipline is required, and the candidate must be willing to travel globally.