Researcher, RA System & Compliance
As RA System & Compliance Researcher, you will be searching, analysing, reviewing and summarizing latest standard and regulation requirements for condom, latex sheet and glove segment.
- Search, analyse, review and summarize latest standard and regulation requirements for condom, latex sheet and glove segment.
- Assist on technical regulatory requirement for country registration matter including product registration, certification, external testing, product & standard compliance, etc.
- 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.
- Prepare, update and compile supporting documents for new and existing customer for country registration especially for condom and glove segment.
- Prepare, update and compile supporting documents for new and existing customer for tender participation.
- 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.
- Preparing Documents for new 510 (k) submission for any new product development especially condom and glove segment.
- 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.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Minimum Bachelor Degree in science, Chemist, Chemical Engineering, Law/ Legal, Business Administration or equivalent discipline.
- Knowledge of relevant Regulation, Standard and Compliance requirement for medical device.
- Relevant work experience is an added advantage.
- Good command of English & Malay (spoken and written).
- Results oriented, strong follow up and good negotiation skills.
- Pleasant personality and able to interact all level of people.
- Experience of working in an international environment, dealing with a variety of cultures and connecting across various time zones.
- Effective collaborative skills, working with key business stakeholders and cross-functional teams.