Assistant Manager - Regulatory Affairs

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Responsibilities

1. Ensure products manufactured or distributed comply with the required regulations.
2. Manage and facilitate all regulatory submissions related to establishment and product.
3. Liaising with regulatory authorities and designated agents.
4. Provide regulatory support to product development and current marketed product.
5. Keep up to date with changes in regulatory.
6. Ensure company compliance with required regulatory.
7. Updating regulatory documentations.
8. Review labelling, storage and packaging requirements in accordance to regulatory requirement.
9. Responsible for reviewing, documenting, logging, maintaining and/or initiating the investigation of potentially serious complaints.
10. Address CAPA deficiencies arising from scheduled and/or unscheduled audits, and customer complaints with special focus on effective corrective action and sustainable preventive action.
11. Conduct Quality Audits.
12. Provide training, guidance and coaching to subordinates (if any).
13. Any other tasks assigned by the superior.

Requirements

1. Bachelor Degree in Science or Engineering or any equivalent.
2. Minimum 6 years of experience in Medical device regulatory position or similar roles and responsibilities preferred.
3. Manufacturing processes and operations.
4. Products testing, licensing, registration and certification.
5. Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
6. Good compliance with organization processes and systems and regulatory requirements.
7. Assisted manager in preparing documentation, drafting product information for product registration or licensing.
8. Sound knowledge in regulatory of medical devices.
9. Addressed CAPA deficiencies with special focus on effective corrective action and sustainable preventive action.
10. Successfully handled customer inquiries and resolved regulatory compliance issues.
11. Ability in scheduling and coordinating the work and activities of others to accomplish tasks assigned.
12. Being able to establish strong relationships with other units or divisions and maintaining them over time.
13. Led cross-functional taskforce consisting of team members from other units or divisions.
14. Coached junior team members in delivering results.

How do your skills match this job?

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How much notice are you required to give your current employer?

Manufacturing, Transport & Logistics 5,001-10,000 employees.

The Hartalega story began in 1988. Our insatiable appetite to constantly surpass our own achievements has transformed what started as a single-line production facility into what we are today, the leading nitrile gloves manufacturer in the world, with a growing capacity to produce billions of gloves every year. We export to over 70 countries across five continents, namely Americas, Asia, Europe, Australia and Africa.

As an industry leader, we pave the way forward through our commitment to innovation. We invented the world's first lightweight nitrile glove, which revolutionalised the industry by shifting the global demand from latex to nitrile gloves. Today, we are home to advanced proprietary manufacturing technology that allows us to safeguard the quality of our products and the efficiency of our operations. Our unrivalled proprietary technology provides us with an important competitive edge as we own the fastest production lines in the industry, producing more than 45,000 gloves per hour.

In all that we do, we are guided by our SHIELD (Synergy, Honesty, Innovation, Excellence, Learning, Dedication) values to do the right thing at all times. As we continue to grow by leaps and bounds, we are single-minded in ensuring that we make a meaningful difference by enriching lives, from the healthcare practitioners and the people they care for to our very own #TeamHartanians, stakeholders and the community. We welcome like-minded individuals to be part of our exciting team. Together, let us make a difference.

Perks and benefits: Medical, Education support, Sports (e.g. Gym), Parking, Profit sharing plan, Fully subsidized company host.