Regulatory Affairs Specialist, Southeast Asia
Singapore
Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
We are looking for people who are keen to try something new:
The person will be responsible for SEA Regulatory Affairs activities which include reviewing internal processes, document and reports pertaining to GDPMD/S certification and re-certification, establishment of licenses, FSCA, product registrations and ensuring compliance with corporate risk management and external authorities.
- Prepare, submit and monitor S.E.Asia product registrations with local authorities.
- Ensure compliance with S.E.Asia regulatory affairs regulation pertaining to product variations, adverse events, field safety corrective actions, product recalls.
- Liaise with relevant sales division on sales and marketing strategy to ensure timely approval of registrations to meet new product launches.
- Ensure timely renewal of product registrations with local authorities.
- Provide regulatory information for tenders, import custom clearance and other submissions.
- Lead and coordinate all internal audits and external certifications for ISO9001 and GDPMD/S, including audits of other sites as lead or co-auditor.
- Work closely with the Quality Manager SEA for successful implementation of Quality initiatives. This will include supporting the Quality Manager in obtaining any recognized international standards certification across all business groups.
- Lead workplace safety and Health Risk Management.
- Responsible for Regulatory Affairs matters for Medical Division and Vision Care S.E.Asia
- Regular information to the executive management on Regulatory affairs and Risk Management Compliance related issues, procedures, key performance indicators and trends as well as regulatory affairs cost.
Key Requirements
- Bachelor’s Degree in Science and/or Engineering
- Minimum 5 years of relevant work experience in Quality Management Systems & Regulatory Affairs in ISO9001 or Good Manufacturing Practice (GMP) environment
- Continual improvement programs and regulatory affairs
- Very good verbal and written communication skills
- Familiar with the medical device industry
- Team player with the ability to work across functions
- A keen eye for details and result driven approach
- Problem solving skills, solution driver, analytical and process oriented
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
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