Regulatory Affairs Specialist

3 days ago

Singapore Agilent Technologies, Inc. Full time

As a Regulatory Affairs Specialist, you will develop and implement programs and processes and provide support to ensure that Agilent products are safe, legal, and meet or exceed customer expectations and quality in compliance with regulations, standards, company policies, and business objectives.

You will perform activities which include:

- Keeps abreast about and maintains record of new or updated national, regional, and global regulatory requirements.
- Prepares and reviews regulatory documentation submissions, license renewal and registrations (including change notifications and amendments) for assigned products in alignment with the registration requirements and company policies.
- Proactively manages the changing regulatory environment for company products by identifying and mitigating areas of risk to prevent barriers to trade and eliminates duplication of effort.
- Reviews product labelling and marketing materials for accuracy and regulations compliance.
- Responds to customers’ and/or authorities’ requests/inquiries and resolves issues regarding regulations and compliance matters.
- Represents company in industry associations and regulatory/standards agencies and participates in industry/local/regional meeting and conference on standards development.
- Provides regulatory support, update, advisory & knowledge sharing to other internal business units and distributors to ensure compliance with the regulations.
- Documents and maintains product registration record and database.
- Leads regulatory projects requiring coordination with other functions.
- Bachelors or Masters' Degree or University Degree equivalent education preferably in Science or Engineering related fields.
- 4+ years' of regulatory affairs experience.
- Good knowledge of regulations and standards (e.g. GMP, ISO 13485) for IVD or medical products/devices.
- Experience liaising with HSA and other regulatory bodies in the region.
- Excellent verbal and written interpersonal skills to persuade and influence others.
- Strong organizational skills to handle documentations and prioritize tasks.
- Good analytical and problem-solving skills.
- Self-driven independent worker who thrives in a team environment.
- Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws._

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