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- Opportunity ID:
- MYO-201723483
- Type :
- Full time
- Position Level :
- Senior Executive
- Industry :
- Management - General
- Job Specialization :
- Engineering - Environmental/ Safety
- City :
- Simpang Ampat
- Description :
- Preparation and support for regulatory submissions
Constructing and maintaining CE Technical files
Maintaining current regulatory status for current products
Maintaining regulatory information required for product import purposes.
Preparation of 510K premarket notification applications for submission to FDA
Preparation of reports and documents to support international regulatory submissions
Preparation of documents and support of activities with Notified Bodies
Participate in the assessment of device changes for regulatory implications
Identifying new or revised regulatory requirements, guidance documents and product standard
Conducting gap analysis when required
Coordinating label/DFU requirements and creation of product labels
Performs internal audit - Requirements :
- Bachelor’s degree in quality, risk management or related field
Year of Experience : Min 5 years
Position Level : Senior Executive
Must be able to speak, read and write English
In-depth understanding and experience with US FDA, CE and ISO Regulatory requirements
Ability to work independently and cope with changing priorities, and to prioritize work load to meet datelines
Competency in MSWord, Adobe Acrobat and Excel - Lowest Qualification :
- Bachelor Degree
- Closing Date :
- 9/29/17, 12:00 AM
Engineered Medical Systems Malaysia Sdn Bhd
- Phone :
- 604-5041252
- Address :
- 1114, Jalan Perindustrian Bukit Minyak 18, Penang Science Park, 14100 Simpang Ampat, Penang. Malaysia
- City :
- Simpang Ampat
- State :
- Pulau Pinang
- Country :
Description
EMS, Engineered Medical Systems is an ISO 13485 Medical Device Manufacturer located in Penang. We have a modern manufacturing plant within the Penang Science Park. Incorporated in 2014, we are a privately held company specializing in manufacturing devices to clients specifications and developing and manufacturing our own line of proprietary disposable air management products.
Benefit
Attractive remuneration package awaiting suitable candidates, it really does make sense to become a part of our family
