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Executive, RA System & Conformance

Job Req ID:  100903
Date:  01-Jul-2022
Department:  RA System & Conformance

Shah Alam, 10, MY, 40170

Working Hours:  Monday to Friday (Regular hours), one Saturday in

Job Descriptions

Job Responsibilities
01) Search, analyse, review and summarize latest standard and regulation requirements for condom, latex sheet and glove segment.
02) Assist on technical regulatory requirement for country registration matter including product registration, certification, external testing, product & standard compliance, etc.
03) Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires for condom, latex sheet and glove segment.
04) Prepare, update and compile supporting documents for new and existing customer for country registration especially for condom and glove segment.
05) Prepare, update and compile supporting documents for new and existing customer for tender participation.
06) Liaison with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review for establishment and product registration especially for condom, latex sheet and glove segment.
07) Preparing Documents for new 510 (k) submission for any new product development especially condom and glove segment.
08) Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Recommend changes to company procedures in response to changes in regulations or standards.
09) Prepare or maintain technical files as necessary to obtain and sustain product approval.
10) Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
11) Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
12) Advise project teams on subjects such as premarket regulatory requirements, export and labelling requirements, or clinical study compliance issues.
13) Shall take additional responsibility as instructed by the immediate Superior.
14) The scope of authority shall refer to the selected work process procedure instruction.

Job Requirements
01) Minimum Bachelor Degree in science or equivalent discipline.
02) Knowledge of relevant Regulation, Standard and Compliance requirement for medical device.
03) Relevant work experience is an added advantage.
04) Good command of English & Malay (spoken and written).
05) Results oriented, strong follow up and good negotiation skills.
06) Pleasant personality and able to interact all level of people.
07) Experience of working in an international environment, dealing with a variety of cultures and connecting across various time zones.
08) Effective collaborative skills, working with key business stakeholders and cross-functional teams.

Why Join Us?

Top Glove is proud to be the employer of choice of 10,000 employees from diverse background. We provide career growth opportunities to our people and encourage innovation as well entrepreneurial ideas to support our vision and mission.

At Top Glove, we are on the lookout for young talents and experience professionals with quality mindset. As the world’s largest rubber glove manufacturer, we are continuously expanding rapidly, and invite qualified individuals to join and grow with us.