Regulatory Affairs Specialist

4 weeks ago

Kuala Lumpur, Malaysia BD Full time

We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

**Why Join Us?**

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a **maker of possible **with us

**Responsibilities**:

- Work in collaboration with project team support update of product Technical Documentation Files based on EU MDR requirements.
- Review existing technical documentation for gaps to the EU MDR requirements and update corresponding technical documents in collaboration with team members.
- Summarize technical information and determine if the technical information meets EU MDR requirements.
- Provide support required for CE marking activities, including preparation and maintenance of product technical files
- Support the development of EU MDR compliant Technical Documentation (Technical Files, Design Dossiers).
- Supports international registrations and product release to market activities.
- Perform other duties and assignments as required.

**Qualifications**:

- B.S. or equivalent with emphasis on material science or mechanical engineering. Professional certifications preferred.
- 1-2 years of experience in medical devices required (must have experience in one of the following areas in medical devices: Regulatory Affairs, Quality or R&D).
- Knowledge and experience with regulatory requirements for medical devices (CE mark technical files and design dossiers).
- Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.
- Working knowledge of statistics and electronic documentation and information systems.
- Ability and desire to travel as needed.

Knowledge, Skills, and Abilities:

- Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
- Strong communication (written, oral) and project management skills.
- Must be able to handle multiple tasks with attention to detail with limited supervision.
- Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
- Comprehensive knowledge of regulatory requirements for absorbable and implantable devices.
- Comprehensive knowledge in new product regulatory strategies.
- Working knowledge of EU, US and international medical device regulations.
- Effective English communication skills, oral and written.
- Demonstrated ability to influence others.
- Demonstrated ability to effectively handle multiple project priorities.
- Excellent organization & prioritization skills.
- Demonstrated problem solving skills.
- Project management/facilitation skills.
- Able to support US-region (east coast) normal working time periods.
- Excellent follow-up and documentation skills

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Primary Work Location**: MYS Kuala Lumpur - Jalan Kerinchi

**Additional Locations**:
**Work Shift**: MY2 Night 9p-6a Mon-Fri (Malaysia)

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