Director, Quality and Regulatory

2 weeks ago


Batu Kawan, Malaysia Haemonetics Corp. Full time

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

JOB SUMMARY

As the leader of the regional RA and QA functions, this individual will manage a staff of regulatory and quality professionals to insure the quality and compliance of all products marketed in the region. This will include careful management of the distribution of self
- manufactured, contract manufactured, and distribution of medical devices, in-vitro diagnostics devices and some pharmaceuticals. This individual will be the face of quality and regulatory to the internal organization, regulators and our customers for the region. In addition, he or she will represent the company in all regulatory conversations, assessments and negotiations on the licensing and quality of our products. The position will partner with the other regional heads of Quality and Regulatory, Europe and the Americas to address product quality, quality system, and regulatory licensing.

ESSENTIAL DUTIES

Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Enter Responsibilities/Essential Duties

Manages the Quality and Regulatory Staff to ensure efficiency and productivity, including meeting financial expectations

Responsible for licensing and maintenance of all products on market in the region, is the primary liaison with government agencies for regulatory and quality issues. Manages all regulatory interactions effectively.

Provides guidance to Regulatory staff in coordinating the preparation of regulatory submissions. Hands on preparation of documentation for product approval may be necessary.

Assists in the launch of all new product platforms in region by effective monitoring of the customer perceived quality

Stays abreast of all regional regulatory changes that could impact the efficacy of any product on market in the region

Liaise with global and local management to expedite preparation of documents required to gain regulatory product approvals.

Continuous monitor and ensures the quality of all products on market in the region

Responds urgently and effectively to quality or compliance concerns

Responsible for communication & oversight of Field Actions in the region.

Forms productive relationships with key customers.

Manages the quality aspects of a third party logistics distribution and refurbishment facility.

Manages the quality system and associated changes for the region.

Ensuring that the EMS conforms to the requirements ISO 14001.

Reporting the performance of EMS including environmental performance to top management

Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.

Education Level Required/Preferred

Bachelor's Degree

Quality, Engineering, Science or Life science discipline or equivalent

Required

Experience Details Required/Preferred

5 years - progressive experience in both RA and QA roles in the market required

7 years - people management required
- EEO Policy Statement



  • Batu Kawan, Malaysia PILOT Construction Sdn. Bhd. Full time

    **POSITION**:Safety and Health Officer **RESPONSIBILITIES** Advise management on issues pertaining occupational safety and health policies, procedures and program as stated in OSHA 1994, FMA 1967, CIDB Act 1994 and other related legal requirements. Plan, implement, manage and review occupational safety and health policies, procedures and program to ensure...

  • Clerk (Marketing)

    4 days ago


    Batu Kawan, Malaysia UWC Industrial Sdn Bhd Full time

    Must be computer literate. - Fresh graduate are encourage to apply - Able to work independently, self motivated and well organized - Good interpersonal and communication skills, mature, dedicated and responsible - Able to work independently and under pressure with high degree of confidentiality - Report to Business Development Manager - Key in quotation...


  • Batu Kawan, Malaysia Lam Research Full time

    **Responsibilities**: This role, an Asia-based member of the Global Legal Services team, is responsible for direct and indirect supply chain agreements, and purchase of materials, parts, and professional services regionally and globally; drafting and negotiation; ensuring compliance with laws and Lam’s corporate polices. Responsibilities for the position...

  • Chief Chef

    4 days ago


    Batu Pahat, Malaysia TOP VICTORY GROUP SDN BHD Full time

    1) Head chefs manage the kitchen to oversee the preparation, cooking and service of food. 2) Overseeing all F&B departments-Korean BBQ & Korean Traditional Cuisine. 3) To modify and create new menus and combine with Korean Authentic recipes as needed so that the operation remains effective. 4) Develops standard recipes and techniques for food preparation and...

  • Finance Executive

    2 weeks ago


    Batu Pahat, Malaysia YOUBABY MILLION SDN BHD Full time

    1. To assist in monthly accounts closing, including preparation of financial statements, supporting schedules, tax computations and related matters. 2. To handle statutory audits and ensure compliance with regulatory requirement. 3. Conducting reviews and evaluations for cost-reduction opportunities. 4. Monitor the day-to-day financial operations within the...


  • Batu Caves, Malaysia LS GASKETS AND AUTO PARTS TRADING Full time

    1) Bersih tempat kerja 2) Sapu dan mop lantai 3) Bersih dinding, tingkap dan permukaan tempat kerja 4) Cuci tandas 5) Buang sampah harian 6) Mengemas dan mengatur barang We are automotive and engineering enthusiasts who strive to provide good quality spare parts for our customers since 1979. We make gaskets, washers and cables for automotive, engineering and...

  • Jr HR Executive

    20 hours ago


    Batu Caves, Malaysia B-CANYON (M) SDN BHD Full time

    B-CANYON(M) SDN BHD is a company established to manage the brand and operation of a chain of restaurants in Malaysia by the name of ‘Black Canyon’. Black Canyon Restaurant originates from Thailand where they have over 200 outlets throughout Thailand and also outlets in other Southeast Asian countries. In the year 2001, our Managing Director bought over...


  • Batu Caves, Malaysia NINJA TECH LAB NETWORKS SDN BHD Full time

    **Administrative Coordinator** responsibilities include supporting regular office operations, screening phone calls and scheduling internal meetings. Ultimately, you will provide administrative support and ensure all daily procedures run smoothly. **Responsibilities** - Manage and route phone calls appropriately - Process and report on office expenses -...

  • Mechanical Design Engineer

    Found in: Talent MY C2 - 2 weeks ago


    Batu Caves, Malaysia Mersing Group of Companies Sdn Bhd Full time

    Responsibilities:Compile and understand requirements for custom designs, modifications, enhancements and upgrading of trenchless machineries.Design and develop mechanical, hydraulic and electromechanical systems for the trenchless industry, considering factors such as performance, reliability, and cost-effectiveness.Conduct feasibility studies and analysis...

  • Preschool Principal

    5 days ago


    Batu Pahat, Malaysia Tadika Cemerlang Intelek Full time

    Job Description: Responsible for ensuring the daily operation runs smoothly, remains safe, and provides an excellent learning environment for the students. To provide instructional leadership, managing and leading the staff and overseeing the facility and budget. 1.1 Marketing and Student Enrolment - Manage Facebook page to increase centre branding and...


  • Batu Pahat, Malaysia United Overseas Bank Full time

    Manager/Snr Officer, Account Mgr/Marketing Mgr, Business Banking, Batu Pahat Branch Posting Date: 23-May-2023 Location: Batu Pahat, Johor, MY Company: United Overseas Bank (Malaysia) Bhd About UOB United Overseas Bank Limited (UOB) is a leading bank in Asia with a global network of more than 500 branches and offices in 19 countries and...

  • Production Clerk

    Found in: beBee S MY - 3 weeks ago


    Kampung Batu Empat Klang Selangor Malaysia 42200 Tubo Steel Industry Sdn Bhd Full time

    Data Entry: Inputting production data, such as quantities produced, materials used, and equipment downtime, into computer systems or spreadsheets accurately and in a timely manner.Inventory Management: Assisting with inventory control by monitoring stock levels, conducting regular counts, and reconciling discrepancies between physical inventory and...

  • Production Clerk

    Found in: beBee S MY - 4 weeks ago


    Kampung Batu Empat Klang Selangor Malaysia 42200 Tubo Steel Industry Sdn Bhd Full time

    Data Entry: Inputting production data, such as quantities produced, materials used, and equipment downtime, into computer systems or spreadsheets accurately and in a timely manner.Inventory Management: Assisting with inventory control by monitoring stock levels, conducting regular counts, and reconciling discrepancies between physical inventory and...