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10 กรกฎาคม 2563
รหัสงาน: BK-229709
Regulatory Affairs & Quality Compliance Manager

Location: 3M Rama 9 Office, nearby MRT Rama 9
The Role:

Reporting into the Asia RA Leader, you will be responsible for the Regulatory Affairs & Quality Compliance (RAQC) for Health Care and Consumer Health Care Business Groups (HCB&CHCB)

The job holder will represent 3M Thailand HCB and CHCB in official communications and issues with health care regulatory perspectives.

Successful execution in this role is key to perform the effective and efficient operations of the regulatory function to support import/export compliances, and directly related to safeguard 3M HCB and CHCB free from regulatory risk and improve long term financial performance of 3M Company.

Job Responsibilities:

  • Hold Regulatory Affairs accountable in all pre-market registrations and share the post-market surveillance (PMS) responsibility with PMS RA Leader to ensure all regulatory activities met with Thai FDA and exporting country regulations.
  • Hold Quality Compliance responsibility to support Quality Management System (QMS) deployment and Quality initiatives to remain product safety and performance.
  • Develop and execute the RAQC strategy imperatives to align with the regional and corporate regulatory policy and management team direction.
  • Act as regulatory liaison for businesses divisions and health care manufacturers to ensure the product safety and performance to meet with Thailand and region/corporate HCB policy.
  • Serve as an active leadership member in Thailand HCB and CHC business leadership teams to support business growth.
  • Collaborate with the business and function stakeholders to ensure RAQC goals are achieved to support organizational growth plan.
  • Develop the standard operating procedures to improve the operational efficiency and effective communication flow.
  • Act on the leadership behavior for significant deviation events that may impact compliance status or significant business risk.
  • Manage the relationship with our health authorities and Notified Bodies to support RAQC goals.
  • Monitor and assess the regulatory changes to ensure we take action to manage the changes and meet with government requirement.
  • Participate in RAQC industry working group to assist with the regulatory harmonization of AMDD
  • Assist and execute regional project as assigned by Asia RAC Leader

 

Job Qualifications:

  • Bachelor or Master of Science or Biomedical Science related
  • Relevant Experiences and qualifications in health care industry required:
  • Around 10-15 years of regulatory working experiences in Thailand medical device industry.
  • Around 5-10 years leadership experiences to drive organizational growth
  • Strong communication and inter-personal skills for effective business support
  • Independent and proactively working on business solutions
  • Strong team player and able to develop the group synergy for productive support
  • Project management knowledge and skills are preferred for task management
  • ISO 13485 or QMS knowledge and experiences will be plus to succeed the role.
  • Have own car and driving license

 


รายละเอียดงาน:

สวัสดิการ
  • ทำงานสัปดาห์ละ 5 วัน

3M is a 30 billion global diversified technology company with leading position in Consumer and Office Markets; Display and Graphics Markets; Electronics and Telecommunications Markets; Safety, Security and Protection Services Markets; Health Care Markets; Industrial and Transportation Markets. For more than 100 years, and 50 years operation in Thailand, we've created innovative technologies and products that meet real customer’s needs all by bringing out the best in our employees. As an equal opportunity employer, 3M have the culture, values, opportunities and challenging work that makes your job a career. If you have a "can-do" attitude with the following academic qualification, come catch the spirit of innovation at 3M.
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