
Regulatory Affairs Lead (SEA)
Permanent Cecelia Koh posted 1 month ago Shortlist Email JobDetails
- Category Commerce & Industry
- Industry Health & Life Sciences
- Function Regulatory Affairs
- Consultant Cecelia Koh
- License No 16S8060
- Registration No R1106833
- Job Ref No CK26180
- Salary S$150,000 - S$250,000
Description
- Medical Device Sector
- Start Up & Entrepreneurial Environment
- Strong PE Backed Portfolio Company
Our client is a new start up, backed by a strong and established PE headquartered in Asia. They are on an aggressive growth path, with ambitions to grow the SEA business as a first priority. In the belief that RA is a key enabler and driver in achieving this growth, there is now a great opportunity for an experienced and ambitious Regulatory Affairs professional to join them.
Role
Working very closely with the CEO, and as part of the senior leadership team, you will provide expert counsel on the direction, product line, routes to market etc. in the very early stages of growth. Technically, you will oversee the preparation, filing and maintenance of all regulatory documents to the relevant health authorities. Over time, and as the business grows, you can be expected to build a team of RA professionals in specific markets of interest. As the company also counts on growing inorganically via M&A, you will also be expected to conduct the necessary M&A due diligence, from an RAQA perspective.
Requirements
Ideally, you have a relevant degree with a minimum of 15 years of experience within the medical devices industry. A good understanding of SEA RA requirements will be a key pre-requisite for the role. You are well-versed with mandatory quality management systems requirements across SEA markets. You are strategic in mindset, a strong business partner and an effective communicator. Entrepreneurial in mindset, you are extremely solutions oriented and are flexible within the allowable parameters of regulatory compliance.
To Apply
To apply, please submit your resume to Cecelia Koh at ck@kerryconsulting.com, quoting the job title and reference number CK26180. We regret that due to anticipated overwhelming response, only successfully shortlisted applicants will be contacted.
L/N 16S8060
R/N 1106833