Regulatory Affairs Manager (Medical Devices)

    By
    penangcat
    -

    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.