Senior Regulatory Affairs Specialist

3 days ago

Singapore Agilent Technologies Singapore Pte Ltd Full time

**Responsibilities**

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 regulations, standards, company policies, and business objectives.

You will perform activities that include:

- Keeps abreast and maintains updated information about national, regional, and global regulatory requirements.
- Prepares, compiles, and reviews regulatory documentation submissions, license renewal, and registrations for new and mature products in alignment with the registration requirements and company policies.
- Manages international registration of Agilent Medical Devices/IVD products, including supporting Channel Partners through the process.
- Supports non-IVD/Medical Devices regulation relating to Hardware (electrical safety, EMC).
- Be the main contact point for Australia Therapeutic Goods Administration (TGA) and Singapore Health Sciences Authority (HSA).
- Proactively manages the changing regulatory environment for company products to prevent trade barriers, eliminates duplication of effort, and identifies and mitigates areas of risk.
- Reviews product labeling and marketing materials for accuracy and regulations compliance.
- Responds to customers' and authorities’ requests/inquiries and resolve issues regarding regulations and compliance matters.
- Represents the company in industry associations and regulatory/standards agencies and participates in industry/local/regional meetings and conferences on standards development.
- Reduces broad concepts/business strategies into structure projects.
- Leads the design and delivery of regulatory programs/solutions as the key technical contributor.
- Resolves complex, high-impact regulatory and/or program/project design problems.

**Qualifications**
- Bachelors or Masters’ Degree or University Degree equivalent education, preferably in a related science or engineering field.
- 6+ years of regulatory affairs experience with medical devices or IVD 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 documentation 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._

**Job Types**: Full-time, Permanent

**Salary**: $4,800.00 - $9,000.00 per month

**Benefits**:

- Free parking
- Health insurance
- Professional development

Schedule:

- Monday to Friday

Supplemental pay types:

- 13th month salary
- Performance bonus

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