Regulatory Affairs Specialist I

1 week ago

George Town, Malaysia Boston Scientific Corporation Full time

**Purpose Statement**:
**Responsibilities**:

- Review and assessment of product and manufacturing changes for compliance with applicable regulations.
- Collaboration with international regulatory counterparts to provide deliverables and ensure compliance to local regulations when developing regulatory strategies and assessing changes.
- Support in Regulatory body audits, such as FDA, BSI, DEKRA.
- Liaise with both middle and senior management on any regulatory issues relating to their area.
- Maintain information in any internal regulatory databases.
- Support and maintain Quality initiatives in accordance with BSC Quality Policy.
- Continuously assess ways to improve Quality.
- Administrative support tasks (e.g., submission support).

**Job Requirements**:

- Minimum of one (1) year Regulatory Affairs or related experience at Medical Device industry.
- Has general knowledge of current and proposed US and EU regulations for medical devices.
- Familiar with ISO 13485 and MDSAP requirements.
- Ability to manage several projects simultaneously with keen attention to detail.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to work independently with mínimal supervision.
- General knowledge of product development process and design control.
- Proficiency in the use of computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat.
- Effective written, oral communication, technical writing and editing skills.
- Effective research and analytical skills.
- Team player with good interpersonal skills.

About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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