Quality and Regulatory Affairs Manager

Haemonetics; Simpang Ampat; On-site; MYR 90,000 - 120,000; Full time

Job summary

A leading medical device company is seeking a Regulatory Affairs Specialist for their operations in Penang, Malaysia. The role involves ensuring compliance with local regulations, managing quality assurance in the Asia Pacific region, and guiding product development teams on regulatory submissions. Candidates should have at least a Bachelor's degree in Engineering or Science and a minimum of 5 years' experience in regulatory affairs within the medical device sector, along with strong analytical skills.

Qualifications

• Minimum of 5 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry.
• Strong knowledge of regulatory requirements across multiple regions.

Responsibilities

• Ensure compliance with local regulations within the APAC region.
• Compile technical documents for regulatory submissions.
• Provide guidance on local product submission requirements.
• Develop regulatory approval strategies for products.

Skills

Regulatory Affairs

Quality Assurance

Analytical skills

Attention to detail

Education

Bachelor's degree in Engineering or Science

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Job Summary:

Responsible for directing activities to ensure compliance with local regulations within Australia and New Zealand, South East Asia, Taiwan, and India Subcontinent areas. Will initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services. Provides regulatory authorities with appropriate documentation ensure licenses are approved and obtained. Establish and maintain relationships with external partners, regulators and opinion formers. Responsible for following regulatory activities at local level.

Provide Quality Assurance and Quality System management in Asia Pacific regions especially in Australia, New Zealand and Taiwan. Assist in establishing, implementing and maintaining the quality management system in APAC. Appointed as Management Representative for Australia and Taiwan. Create and maintain company quality documentation, such as quality policies, procedures, SOP, records & etc. Provides administrative expertise in receipt, processing, monitoring and reporting of product defect complaints, serving as primary contact. Partner with manufacturing facilities, supplier quality and R&D to analyze failures, establish corrective and preventive actions and provide respond to customer complaints.

Job Responsibilities:

• Work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant distribution department to compile technical information for supporting regulatory submissions for the countries of the region.
• Compile appropriate technical documents for local regulatory submissions in Australia and New Zealand, South East Asia, Taiwan and India Subcontinent countries.
• Provide guidance to product development teams regarding specific local product submission requirements.
• Review proposed labeling changes to determine regulatory impact on existing certifications and registrations.
• Lead and work with RA staff within her organization and across Haemonetics, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization.
• Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
• Review new regulatory guidance and participate in the implementation of programs to support compliance
• Communicate with customers to respond to regulatory concerns/questions.
• Maintain product registration data base for Hong Kong, South/East Asia and India Subcontinent, Taiwan and Australia and New Zealand & Distribution countries track regulatory department metrics
• Manage communication about vigilance issues for assigned countries.
• Establish, implement and maintain the quality management system in the regions of Asia Pacific. Create and maintain company quality documentation, such as quality policies, procedures, SOP, records & etc
• Ensure product complaints are managed according to corporate procedures.
• Conduct complaint analysis and trending and establish improvement plan
• Ensures that all product complaints from the assigned region are screened for potential safety issues, reported accurately, and complaints are closed out in a timely manner
• Partners with Field Service, Logistic, Planning, Marketing, Manufacturing, Quality and Sales personnel to help resolve customer issues.
• Ensure 3rd party logistics in Asia Pacific regions comply with local regulation requirements and company policies.

Job Requirement:

• Bachelor’s degree in Engineering, Science, or equivalent qualification
• Minimum of 5 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry
• Strong knowledge of regulatory requirements across multiple regions, including the US, EU, Hong Kong, Southeast Asia, Taiwan, Australia, New Zealand, and the Indian subcontinent
  Proven experience with product registration processes and regulatory submissions across these regions
• Excellent attention to detail, strong analytical skills, and the ability to manage multiple regulatory projects effectively

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