Perak Jobs Regulatory Affairs Executive Position at ITL Asia Pacific Sdn Bhd
- Job vacancies posted on: 7 months ago
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Are you looking for job vacancies? Our company, ITL Asia Pacific Sdn Bhd is merrily inform you that we are hiring!
We need you to fill the position as Regulatory Affairs Executive for our office.
This position requires a full time working hours system which domiciled in Perak and its surroundings.
As a competitive company, we need these minimum criteria for candidates to be fulfilled. If you are a Bachelor's Degree, Post Graduate Diploma & Professional Degree and experienced in the field of Services & Lawyer/Legal Asst, a person who honesty and discipline, then you are highly awaited in our company.
The starting salary we can offer is in a range from RM 2,500 - RM 4,000, this salary range that we offer is negotiable can change at any time according to our HRD's decision depending on the capability of the candidate can offered for our company.
Job Info
| Company | ITL Asia Pacific Sdn Bhd |
| Position | Regulatory Affairs Executive |
| Region | Perak |
| Career Level | Junior Executive |
| Work Experience | 2 years |
| Qualification | Bachelor's Degree, Post Graduate Diploma, Professional Degree |
| Type of Work | Full-Time |
| Specialization Required | Lawyer/Legal Asst, Services |
| Minimum Salary | MYR 2.500 |
| Maximum Salary | MYR 4.000 |
Job Description:
- Ensure regulatory compliance of ITL products in which they are marketed.
- Support the company in meeting applicable regulations and regulatory requirements on systems and products.
- Maintain Medical Device Registration / Notification for all applicable markets.
- Preparation of submissions and compilation of documentation in support of domestic and international product marketing approvals. Regulatory submissions may be related to new products, new intended uses for existing products, and introduction of existing products into new geographies.
- Liaise with relevant internal and external parties for new markets exploration, including understanding country’s specific requirements and estimated time to market.
- Ensure Technical Documentations are prepared and submitted in according to regulatory requirements.
- Maintenance of regulatory documents and records.
- Assisting / Preparing / Participating in internal and external audits.
- Support team member in assigned tasks within departmental functions.
Requirements:
- Diploma or Degree in Science / Law / Engineering with preferably minimum 2 years of regulatory affairs experience in a medical device/pharmaceutical manufacturing company
- Good technical writing skills.
- Excellent written and spoken English (grammar, comprehension & vocabulary)
- Preferably familiar with ISO 13485, US FDA 21 CFR Part 820, Australian Therapeutic Goods Administration, Medical Device Directive 93/42/EEC, European Medical Device Regulation, European In Vitro Diagnostic Regulations, Malaysia Medical Device Regulations Act (Act 737), MDR and IVDR.
Office/Company Address
| Country | Malaysia |
| Region | Perak |
| Address | Itl Asia Pacific Sdn. Bhd., 29A, Jalan Pengkalan, Kampung Tersusun Pengkalan Pegoh, 31500 Ipoh, Perak, Malaysia |
| Map | Google Map |
Benefit
- Australian based multi-national company
- Outstanding career development opportunities
- Exciting role in regulatory requirements
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Company Description
Over the past 20 years, ITL BioMedical has become a leading global provider of medical devices and systems forsafer, more efficient biological sampling and clinical best practice.
Our products provide support for blood collection, blood culture testing, blood sample transfer, pre-analytics, invasive blood pressure monitoring, IV administration, medical procedures, haemostasis applications, surgical needs and animal healthcare.
As a world-class medical device manufacturer, we prioritize safety, efficiency, and ease of use.
We are held to the highest quality and regulatory standards in the industry, and here’s why blood banks, laboratories and clinical markets trust us. We consistently look to the future and leverage input from healthcare markets worldwide to advance our products. We work closely with our customers to meet their changing needs through continuous product innovation, quality control and outstanding customer service. Our research and development lab rigorously test our advancements to ensure our devices are designed with superior quality when introduced on a global scale. Our global network of sales, distribution and service team members ensure worldwide access to our products, which are used daily in more than 55 countries.
Company Info
- Industry: Manufacturing / Production
- Registration No.: 481256-T
- Company Size: 201 - 500 Employees
- Average Processing Time: 16 days
- Benefits & Others: Medical, Regular hours, Mondays - Fridays, Formal (e.g. Shirts + Ties), Hospitalisation/Group Insurance
- Specific Location: Bemban, Batu Gajah
