Job Description

Principal Regulatory Affairs and Quality Specialist - AGM

Job no: 615794
Work type: Permanent
Location: Kuala Lumpur, Singapore
Categories: Quality & Regulatory, Individual Contributor


Cochlear\xe2\x80\x99s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people\xe2\x80\x99s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear\xe2\x80\x99s Asia Growth Markets (AGM) headquartered in Singapore, the AGM region incorporates countries within South and South-East Asia, including Singapore, Indonesia, Malaysia, Thailand, Vietnam, Philippines, Pakistan, and Sri Lanka. AGM currently uses both direct and distributor business models. We are a relatively young region, with ambitious but achievable growth targets. The Opportunity We are seeking a Principal Regulatory Affairs and Quality Assurance Specialist, to join our team. Reporting, directly to our Director, Regulatory Affairs APAC and based in either Singapore or Malaysia, the successful candidate will have the opportunity to champion the growth and compliance of Cochlear Asian Growth Markets (AGM) business by leading and implementing regulatory strategy and managing Quality Management systems that enable our growth. Responsibilities include: Regulatory Champion/Representative

• Provide critical regulatory timelines to support accurate planning, forecasting and budgeting for the AGM Markets
• Champion and represent AGM when liaising and collaborating with Global and Asia Pacific (APAC) counterparts for Regulatory Affairs requirements as part of the Cochlear Product Innovation Process.
• Lead a culture of business (code of conduct)/regulatory (local legislation) compliance in AGM and provide guidance and support to the Cochlear team and distributor team members to ensure compliance

Regulatory Product Registrations

• Implement product registration plans and communicate status to relevant stakeholders to deliver timely product submissions and approvals
• Participate in the APAC New Product Introduction (NPI) process to ensure that all regulatory requirements are communicated between AGM and APAC and satisfied for timely product launch

Quality Management System

• As the Quality representative for AGM, fulfil all requirements related to the quality function in partnership with the Global and APAC Regional teams
• Establish and maintain a Quality Management System that supports operational excellence and achieves Good Importation Practice (GIP) and Good Distribution Practice (GDP) certification across AGM markets

Surveillance and Compliance

• Partner with the AGM Marketing team to develop marketing collateral and procedures that are complaint with regulatory standards
• Participate in Cochlear\xe2\x80\x99s post market surveillance system and ensure that it is compliant with AGM\xe2\x80\x99s regulatory requirements

You Bring Your Skills and Experience As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you\'ll be able to demonstrate the following skills and experience:

• Bachelor\xe2\x80\x99s degree in engineering, pharmaceutical science, medical, legal, science or relevant field
• 8+ years of professional experience in regulatory affairs with demonstrated knowledge/experience in:
  • Broad knowledge of medical device regulations associated with the product development and approval process in Southeast Asia
  • Proven track record of management, compilation, submission, approval and maintenance of regulatory filings
  • Interacting directly with government agencies, industry bodies and health care professionals in order to meet designated timeframes and maintain compliance
  • Creativity, foresight and ability to provide input into activities of importance
• Strong written and verbal English language skills
• Demonstrated leadership qualities; sound judgment, engaging interpersonal skills, effective communication, ability to negotiate and influence, initiate collaboration and project manage
• Collaborative mindset and team player across culturally diverse stakeholders
• Ability to work under pressure and to tight deadlines
• Ability to work autonomously in performing tasks according to an agreed plan

Something else to grab our attention.

• 5+ years of professional experience in quality management systems, post-market quality and Good Distribution Practices
• Domain expertise with new introduction of new medical technology in one of the key markets, Thailand, Indonesia, Singapore, Malaysia
• Southeast Asia level exposure will be a bonus
• Experience in market access projects

In turn, you will have the unique opportunity to work in a multinational, Australian-owned organization engaged in delivering life changing technology. As you manage regulatory and quality for Cochlear\xe2\x80\x99s Asia Growth Markets region, you will gain exposure to a diverse set of markets. Share in the excitement of bringing new technologies to market and seeing the profound impact that it has in the lives of the hearing impaired. For more information about Life at Cochlear, visit www.cochlearcareers.com How to apply. If you are excited about what you have read and would like to be considered for this role then please submit your resume and a covering letter detailing your suitability for this role. At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We\'re open to a conversation about what flexibility means for you. Advertised: 21 Feb 2023 Singapore Standard Time
Anticipated Application Closing: 12 Mar 2023 Singapore Standard Time