- Category Commerce & Industry
- Industry Health & Life Sciences
- Function Regulatory Affairs
- Consultant Cecelia Koh
- License No 16S8060
- Registration No R1106833
- Job Ref No CK25160
- Salary Above S$250,000
- Established US MNC
- High Growth Potential
- Competitive Remuneration
Our client is renowned for being a trail blazing innovator within the Medical Devices sector. As they continue to grow and embark on exciting new product launches in the region, there is now an exciting opportunity for a seasoned RAQA Director to join them.
Reporting to the SVP Regulatory Affairs based in the US Headquarters, you will be a senior member of the APAC Leadership Team in driving robust RAQA activities. Leading a remote team in the region, you will provide leadership, counsel and guidance over the preparation, filing and maintenance of all regulatory documents to the relevant health authorities, as well as oversee the maintenance of databases as a reference for global and regional cross functional teams. Naturally you will be expected to engage with in-country distributors regarding product registrations, regulatory compliance and quality compliance. As the company embarks on M&A as part of their inorganic growth strategy, you will also be expected to conduct the necessary M&A due diligence, from an RAQA perspective.
Ideally, you have a relevant degree with a minimum of 10 years of experience within the medical devices industry. A good understanding of APAC RA requirements will be a key pre-requisite for the role. You should also be familiar with mandatory quality management systems requirements across APAC markets. You are an effective communicator, solutions oriented and are flexible within the allowable parameters of regulatory compliance. Coming from a place of best in class, you also thrive in new setups and somewhat unstructured environments. As this function cuts across several parts of the business, you work well in a matrixed environment, particularly in the areas of marketing, business and manufacturing, just to name a few.
To apply, please submit your resume to Cecelia Koh at firstname.lastname@example.org, quoting the job title and reference number CK25160. We regret that due to anticipated overwhelming response, only successfully shortlisted applicants will be contacted.