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APAC Regulatory Affairs Manager - In-vitro Diagnostics MNC
- Take on this newly created position to manage a leading Regulatory Affairs team
- Are you customer focused with excellent interpersonal skills?
About Our Client
My client is a market leader in in-vitro diagnostics instruments offering tailored solutions to hospitals and labs across APAC.
They are expanding their Regulatory Affairs and Quality Assurance team and require this new position to be filled by a customer facing, cross functional team player who has a proven capability of leading a small team.
You will report to the VP of Business Admin and Planning and will be key in bridging the gap between your 2 more junior direct reports and senior management.
Your strategic input will be essential to allow for the smooth introduction of new products into the market while working closely with the sales and marketing teams.
The principle duty of this position is to be the point of contact for all regulatory communication for the company, including incident reports, audits, registrations any other regulatory issues
Your key deliverables will be:
- Maintaining and ensuring that the all company products and the quality system meets the regulatory requirements of SEA, SA and Oceania countries and the international market medical device requirements
- Ensuring that the company quality system meets the applicable standards including but not limited to ISO 13485/9001/14001
- Maintaining and ensuring that the company's risk management policy and guideline are managed and updated properly
- The principle duty of this position is to be the point of contact for all regulatory communication for the company, including incident reports, audits, registrations any other regulatory issues
- Establish and maintain compliance with FDA QSRs (GMP) in Asia Pacific countries including new product submissions, establishing FDA communication for compliance on medical device listings, classifications and management of the CAPA system
- Manage and establish certification of ISO 13485, ISO 9001, ISO 14001 and others as required
- Conduct related internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings
- Manage Quality System for products the company is manufacturing and supplying
- Responsible for the Customer Complaint System and generating the monthly customer complaint report
- Manage adverse event reporting, report adverse event to HAS and authorities in APAC countries within the stipulated time-line
- Formulate the regulatory strategic plan for the timely introduction of new products in APAC region
- Review and edit the dossier to comply with regulatory requirements
- Provide support to the company's affiliates and distributors in new product registration, renewals and amendments
- Act as internal consultant on regulatory issues such as recalls or field corrective actions
- Ensure changes to the approved products are submitted to authorities like HSA on time as required
- Ensure and maintain product approvals and licenses, including dealers where applicable
- Accountable for budget and policy recommendations and medium-term planning
- Maintain the knowledge and awareness of current applicable regulations and standards
- Maintain current knowledge of laws for financial, advertising and marketing reporting, regulations and industry guidance that impact the company's compliance program
- Develop employee communication and training programs that focus on the elements of a company-wide compliance program
The Successful Applicant
- Bachelor Degree in Medical Science or equivalent
- 8 years of working experience in Regulatory Affairs or preferably related to in-vitro diagnostics medical device products
- A good understanding of the Quality Assurance and Regulatory framework in APAC countries including the Product Registration Act and Regulations in Singapore, ASEAN CSDT
- Customer focused, team player, responsible, flexibility
- Willing to travel up to 30% of the time
What's on Offer
You will make a significant contribution to delivering the newest diagnostic technologies to the market. As a result your input will have a direct affect on the speed and accuracy of patient diagnosis and laboratory research. This intern will improve the treatment of thousands of people for many years to come.
You will be rewarded with a generous compensation package and variable performance bonus.