Primary Job Functions: Provide administrative support for the activities conducted by the Regulatory Affairs Department. Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.
Secondary Job Functions: Provide support to Regulatory Affairs Department scheduling large event meetings, expense tracking and submission as well as travel planning, purchase order and vendor creation.
Responsibilities:
• Gather, document and maintain regulatory “intelligence information” for pre-market and post market requirements in US and international countries. Monitor new and revised regulatory requirements and disseminate information to affected parties.
• Support RA team in compiling and preparing hardcopy and electronic information packages for submission to regulatory agencies.
• Define, monitor and receive deliverables for submissions.
• Write and/or edit process documents using RA templates, or create new templates in support of continuous RA process improvement.
• Perform other related duties as assigned
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Requirements:
• A Bachelor’s degree or related experience.
• Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products.
• Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks with the supervisor input.
• Excellent written and oral communication skills
• Must be able to gather, write, edit and facilitate assembly of memos, and process product and system information for regulatory purposes
• Strong work ethic and demonstrated ability to deliver assignments on time.
All your information will be kept confidential according to EEO guidelines.
Skills Required
- Bachelor's degree or related experience
- Ability to work independently with technologies and office automation programs
- Excellent written and oral communication skills
- Ability to gather, write, edit and facilitate assembly of information
- Strong work ethic and ability to deliver assignments on time
Collabera Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Collabera and has not been reviewed or approved by Collabera.
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Fair & Transparent Compensation — Pay is considered acceptable to strong on select technical contracts and in certain geographies, with some assignments described as substantially above typical consultant rates. Outcomes appear closely aligned to client budgets and market conditions, delivering solid value in higher‑demand niches.
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Career-Linked Recognition & Rewards — Compensation tends to track niche skills and client demand, leading to more favorable pay for specialized technical roles and markets. This structure helps some cohorts perceive their pay as market‑competitive.
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Wellbeing & Lifestyle Benefits — Offerings include access to mental‑health therapy sessions and gym membership or reimbursement. These additions complement core coverage in some roles.
Collabera Insights
What We Do
In our relentless pursuit of greatness, we are dedicated to developing individuals, creating exceptional teams, and cultivating a unique culture of unity and care. As providers of digital talent solutions, we aim to positively impact businesses and communities globally. We would be honored to be your trusted and uncommon partner on this journey.
