Engineered Medical Systems Malaysia Sdn Bhd
Engineered Medical Systems Malaysia Sdn Bhd is Hiring!
EMS-M, Engineered Medical Systems Malaysia Sdn Bhd is an ISO 13485 medical device manufacturer located in Penang. We have a modern manufacturing plant within the Bukit Minyak Industrial Park. Incorporate in 2014, we are a privately held company specializing in manufacturing devices to client’s specifications, developing and manufacturing our own line of proprietary disposable air management products.
Growing with EMS,
- We provide a clear understanding of our Company’s policies.
- We practice a vibrant and energetic office culture.
- Opportunities of career growth due to the dynamic .environment that the Company is in.
- Our company support fun yet balances working environment.
Regulatory Affairs Manager (Medical Devices)
The Regulatory Manager executes the activities pertaining to submissions and communications with the regulatory bodies. Assesses and develops a regulatory strategy to allow products to be marketed domestically and internationally.
- Preparation for regulatory submissions and support of activities with notified bodies.
- Preparation of 510K premarket notification applications for submission to FDA.
- Constructing and maintaining CE Technical files.
- Maintaining current regulatory status for current products.
- Participate in the assessment of device changes for regulatory implications.
- Identifying new or revised regulatory requirements, guidance documents and product standard.
- Act as liaison for Company with regulatory bodies
- Conducting GAP analysis when required.
- Coordinating label/DFU requirements and creation of product labels
- Preforms Internal Audit.
- Candidate must possess at least Bachelor’s Degree/Post Graduate Diploma/Professional Degree in Engineering, Science or equivalent.
- At least 5 Years of working experience in the related field is required for this position.
- Strong medical device product development and manufacturing experience covering regulatory specialty areas of device registrations, new product development, etc.
- Preferably Manager specialized in regulatory compliance. In-depth understanding and experience with US FDA, MDA, CE and ISO Regulatory requirements.
- Ability to work independently and cope with changing priorities, and to priorities workload to meet datelines.
- Work location in Bukit Minyak Industrial Park, Penang.
*Interested candidates who meet the above criteria are invited to submit their application with a detailed resume stating current & expected salary to Mr. Lim Zi Hao at firstname.lastname@example.org OR call 04-504 1252 (Ext.: 110) for further enquiries.