Sr. Regulatory Affairs Specialist

2 weeks ago

Singapore Agilent Technologies, Inc. Full time

As a Senior Regulatory Affairs Specialist, you will develop and implement programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations, standards, company policies, and business objectives.

You will perform activities which include:

- Keeps abreast about and maintains updated information about national, regional and global regulatory requirements.
- Prepares, compiles and reviews regulatory documentation submissions, license renewal and annual registrations for new and mature products in alignment with the registration requirements and company policies.
- Manages international registration of Agilent Medical Devices/IVD product, including supporting Channel Partners through the process.
- Supports non-IVD/Medical Devices regulation relating to Hardware (electrical safety, EMC).
- Be the main contact point to Australia Therapeutic Goods Administration (TGA) and Singapore Health Sciences Authority (HSA).
- Proactively manages the changing regulatory environment for company products to prevent barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
- 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.
- Reduces broad concepts/business strategies into structure projects.
- Leads the design and delivery of new regulatory programs/solutions as the key technical contributor.
- Resolves complex, high impact regulatory and/or program/project design problems.
- Bachelors or Masters' Degree or University Degree equivalent education preferably in Science or Engineering related fields.
- 4+ years of experience with medical devices or IVD registration in Australia or other countries in the APAC region.
- Good knowledge of applicable regulations and standards (e.g. GMP, ISO 13485) for IVD or medical products/devices.
- Experience in non-IVD/medical devices such as hardware safety / EMC will be added advantage.
- 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 is able to work 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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