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Regulatory Affairs Coordinator

2 months ago

Carlsbad, United States Danaher Corporation Full time

Position Overview:
The Regulatory Affairs Associate plays a crucial role in ensuring compliance with regulatory standards and facilitating the approval process for design documentation.

Key Responsibilities:
- Conduct regulatory assessments and develop plans for design control activities.
- Ensure adherence to regulatory compliance requirements across US, EU, and international standards.
- Assist with post-market activities, including surveillance, adverse event reporting, and field actions.
- Support the review and updating of labeling to meet regulatory standards.

Team Collaboration:
As a member of the Quality Assurance and Regulatory Affairs Team, you will report to the Senior Manager responsible for regulatory compliance. Your role will involve working closely with multifunctional teams to drive improvements and align global projects.

Opportunities for Growth:
In this position, you will have the chance to:
- Contribute to regulatory activities related to escalated complaints.
- Participate in the preparation of documentation for applications, registrations, and responses to regulatory inquiries.
- Engage in process improvements and the creation of Standard Operating Procedures (SOPs) within the regulatory affairs domain.

Essential Qualifications:
- A Bachelor’s degree is required.
- Experience collaborating with diverse teams.
- Strong analytical skills with the ability to navigate complex situations.
- Proficiency in Microsoft Office applications, particularly Excel, PowerPoint, and Word.

Preferred Qualifications:
- A degree in Pharmacy, Biology, or Engineering is advantageous.
- Previous experience in a medical manufacturing environment, particularly in Quality Assurance or Regulatory Affairs, is a plus.
- Fluency in the Chinese language is desirable.

Work Environment:
This position offers a hybrid work arrangement, allowing for a combination of in-office and remote work. Danaher Corporation is committed to fostering a diverse and inclusive workforce, recognizing the value of different perspectives and experiences.

For more information about our commitment to equal opportunity and diversity, please visit our website.