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)
Job Descriptions:
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.
Essential Duties:
- 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.
Job Requirements:
- 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 zihao@engmedsys.com OR call 04-504 1252 (Ext.: 110) for further enquiries.