Coord 3, Regulatory Affairs

Kaygen Inc.

Irvine, CA

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JOB DETAILS

SALARY

$50–$65 Per Hour

JOB TYPE

Temporary, Contractor, Full-time

SKILLS

Analysis Skills, Biology, Career Development, Communication Skills, Community Support, Contract Management, Cross-Functional, Detail Oriented, Distribution Control, Document Management, FDA (Food and Drug Administration), Fortune 500 Customers, Government, Health Insurance, Identify Issues, Interpersonal Skills, Medical Equipment, Mentoring, Metadata, Microsoft Office, Operational Support, Organizational Skills, Problem Solving Skills, Product Lifecycle, Product Management, Protocol Independent Multicast (PIM), Public/Media/Press/Analyst Relations, Regulations, Regulatory Requirements, Seminars, Startup, Team Player, Technical Support, Technical Writing, Time Management

LOCATION

Irvine, CA

POSTED

12 days ago

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

Work schedule: M-F
Hybrid-2 days per week on site.

Job Title: Regulatory Affairs Coordinator 3 (Contract)

Duration: 6 months, with option to extend

Job Description:
We are seeking a highly detail-oriented and accountable Regulatory Affairs Coordinator 3 to support key regulatory operations activities. This role requires strong organizational skills, a high degree of ownership, and the ability to quickly identify and escalate issues while maintaining close communication with assigned full-time team members

Key Responsibilities

Support eIFU activities, including metadata management, completion of required forms, and timely uploads to BD eIFU website

Perform Product Information Management (PIM) entries inputting UDI, EUDAMED and other country UDI database attributes into the system

Execute and support end-to-end distribution-related activities for products across sustaining projects and integration efforts, including certificate lifecycle management, compliance actions such as hard stop holds, distribution control releases for applicable regions (US, EU, ROW), and distribution release closure activities, ensuring alignment with regulatory and operational requirements.

Maintain clear, proactive communication with internal teams to support execution and compliance

Other incidental duties assigned by leadership may include but not limited to:

- Develop and execute global regulatory strategies by collaborating closely with cross-functional teams and regulatory associates around the world
Assess the regulatory impact of device modifications

- Develop robust non-filing justifications for the US and EU in response to product modifications

- Coordinate and prepare letter to files for the US and technical documentation updates for the EU in response to product modifications
  
  Education:
  
  Bachelor's degree in related field or scientific discipline (e.g., Biology)
  
  Experience:
  
  Must haves:
- • Strong attention to detail with excellent organizational, analytical, and problem-solving skills
  • Ability to manage competing priorities in a fast-paced environment
  • Effective communicator and collaborative team partner with strong interpersonal skills and ability to work cross-functionally
  • Demonstrate a strong willingness to learn new processes, tools, and technologies
  • Extensive knowledge and understanding of US FDA (Class II) and EU MDR (Class IIa/IIb/III) regulations relevant to medical devices
  • Experience with authoring EU technical documentation, supporting notify body change notifications in coordination with cross-functional teams, compile and support 510(k) activities, and product lifecycle maintenance
  • Ability to interact professionally with all organizational levels
  • Follow guidance, ask questions, and training to develop role specific skills
  
  Nice to haves:
- Ability to build productive internal/external working relationships
- Coursework, seminars, and/or other formal government and/or trade association training
- Knowledge and understanding of global regulatory requirements relevant to medical devices
- Proficiency in document management systems and Microsoft Office

Shift: ['• Strong attention to detail with excellent organizational, analytical, and problem-solving skills • Ability to manage competing priorities in a fast-paced environment • Effective communicator and collaborative team partner with strong interpersonal skills and ability to work cross-functionally • Demonstrate a strong willingness to learn new processes, tools, and technologies • Extensive knowledge and understanding of US FDA (Class II) and EU MDR (Class IIa/IIb/III) regulations relevant to medical devices • Experience with authoring EU technical documentation, supporting notify body change notifications in coordination with cross-functional teams, compile and support 510(k) activities, and product lifecycle maintenance • Ability to interact professionally with all organizational levels • Follow guidance, ask questions, and training to develop role specific skills']

Start: ['Ability to build productive internal/external working relationships', 'Coursework, seminars, and/or other formal government and/or trade association training', 'Knowledge and understanding of global regulatory requirements relevant to medical devices', 'Proficiency in document management systems and Microsoft Office']

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

Benefits:

Free Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Sick Time Off

Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:

Certifications

Mentorship Program
Referrals
Family and Wellness benefits
Continuous Growth and Career Development

About the Company

Kaygen Inc.

Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation. From structuring data to the Cloud and visualization, Kaygen leads the digital transformation of global clients.

Kaygen, from the Japanese word, kaizen, for continuous improvement, signifies how we continuously seek to bring expert tech talent to our client engagements to create a sustainable competitive advantage. However, there is more. Our company is diverse, and minority woman owned and operated by expert data technologists who have conceived and developed the very strategic technology initiatives that we now engage in for our clients with our talent.

Our core belief in diversity, complemented by the principles of kaizen, ensures we bring the best expert data talent to work transparently, collaboratively, and with the flexibility to ensure client success.

Visit http://www.kaygen.com/ for a solutions overview.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Computer/IT Services

EMPLOYEE BENEFITS

Paid Sick Days, Professional Development, 401K, Employee Referral Program, Flexible Spending Accounts, Employee Events, Life Insurance, Merchandise Discounts

FOUNDED

2003

WEBSITE

http://www.kaygen.com