5 Jobs for Medical & Healthcare found
Regulatory Affairs ManagerID:444829,000 MYR ~ 10,000 MYRBangsar
This role will be responsible for all regulatory affairs (RA) and pharmacogivilance (PV) matters, including but not limited to submission for and maintenance of new drug approval (NDA) of new products and existing products and Import/Wholesaler’s License. Besides, ad-hoc projects will be required to this she/he shall contribute with regulatory input.
1. Product Registration
• To ensure proper submission of NDA to the health authority (NPRA), including but not limited to, compilation of dossiers and preparation of product information (e.g., package insert and artwork of package materials)
• To ensure accurate reporting and compliance to the regulatory requirements.
• To be responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations and registration renewals.
• To establish the work flow process for Regulatory Affairs
• To coordinate with our group companies in Singapore and Japan (and third party partners as the case may be) to obtain the necessary documents and update submission / registration timeline for regulatory dossier submission.
• To provide support or deal with the governmental regulatory authorities to secure Marketing Authorizations (MAs).
2. Import/Wholesaler’s License and QA
• To prepare and submit an application for Import License and Wholesaler License of the Company, and to be the Responsible Person named in such license.
• To prepare, maintain and implement the necessary SOPs and other quality system that meet the requirements of the regulations with respect to product quality and GDP.
• To discuss and agree on the allocations of roles and responsibilities between the Company and parties (e.g., distributor) to ensure appropriate product quality processes.
3. Regulatory Input
• To search, collect, analyse and evaluate the information with respect to regulatory activities, and make and send the report for them.
• To visit regulatory authorities, important medical consultants and key customers in the public and private sectors, when necessary.
• To contribute RA inputs (e.g., regulatory strategies, timelines, labelling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
• To manage safety queries and other significant safety information locally, inclusive of crisis management
• To prepare, maintain and implement the necessary SOPs that meet the requirements of the regulations with respect to drug safety.
• To ensure the proper and timely collection, reporting and managing of safety information of the products of the Company in accordance with the regulatory requirements.
• To ensure sufficient management of safety information to enable head office to perform a comprehensive and accurate assessment.
• To provide non-safety staff with the regular training to ensure that they are aware of their Drug Safety responsibilities.
• To review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
• You may be assigned other duties from time to time.
Work time; 09:00-18:00
Annual Leave 14
Urgent! - Japanese Speaking Customer Relation Executive 2 Opening positionsID:442134,000 MYR ~ 6,000 MYRBangsar
This is a Japanese medical service company established in Malaysia. Their core business is to provide service to Japanese who are living in Malaysia to communicate and assist them in medical treatment. How they provide their service? They act as the middle person and translator between their clients and local hospital staffs. Also, providing ambulance service to those who are involved in accidents together with insurance service.
• Attending hosting company's members to the hospital as a translator for doctor consultation
• Prepare report in Japanese & English.
• Provide general administrative and operational support for assigned task.
• Answering phone calls, email correspondence, ad-hoc duties and update data entry into the computer system.
• Standby on 24 hours support during non-working hour and Weekend at least twice a week.
For more inquiries contact:
1. Send in your latest resume to firstname.lastname@example.org
2. Call in +603-20201885 for more information.
Working Hours: 5 days a week, 0800 - 1700
Salary starting with 4K + benefits
Business trips allowance (taking taxi, Grabs etc.)
Working place Parking,
(Medical support Allowance worth RM 1700)
Medical check up
Claimable medical claim
Medical and overtime allowance
Provide Handphone and reload up to RM85/month
準ビジネスレベルの英語力をお持ちの方必見！クリニック受付・医療通訳ID:418976,500 MYR ~ 8,000 MYRMont Kiara
【勤務エリア】1 Mont Kiara
Project Sales Executive (Medical Project for Hospital)ID:435513,500 MYR ~ 4,500 MYRBukit Bintang
Company Profile: Established about 20 years in Malaysia. They are supplying high quality and user friendly medical equipment to the market such as Sterilization , Medical bed, Automation System for Washer Disinfection, Patient Transfer Solutions, Therapeutic Support Systems, Hygiene Systems and more.
Reporting to Division Manager (Sales Manager)
< Main >
-Liaise with main con construction JKR / KK to get a project to supply medical equipment to the hospital.
- You will drive all aspects of sales and business development of Getinge full range of infection and associated equipment to key accounts in the government and private sector Hospital.
- You are responsible for medical sales to the highly competitive government and private sector, working alongside the project team.
- You are responsible for seeking new opportunities in this market, which includes identifying key customer groups and generating new business in tis high growth potential area.
- Service existing accounts, obtains orders and establishes new accounts by planning and organizing daily work schedule to call on existing or potential sales outlets and other trade factors.
- Adjusts content of sales presentations by studying the type of sales outlet or trade factor.
- Focuses sales efforts by studying existing and potential volume of customers.
- Submits orders by referring to price lists and product literature.
- Keeps the division Manager of Infection Control informed by submitting activity and result reports, such as daily call reports, weekly work plans, and monthly and annual territory analysis.
- Monitors competition by gathering current marketplace information on pricing, products, new products, delivery schedules, merchandising techniques, etc.
- Recommends changes in products, service, and policy by evaluating results and competitive developments.
- Resolves customer complaints by investigating problems; developing solutions; preparing reports; making recommendations to management.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Provides historical records by maintaining records on area and customer sales.
- Contributes to team effort by accomplishing related results as needed.
14 days annual leave
reimbursement for tol and petrol.
outstation RM0.45 per km
【ペナン勤務】準ビジネスレベルの英語力をお持ちの方必見！クリニック受付・医療通訳ID:427995,000 MYR ~ 8,000 MYRGeorgetown