Regulatory Affairs Associate
About The Position
Zymo Research is looking for a motivated individual to join our Regulatory Affairs team! In this role, you will play a vital part in supporting regulatory activities and maintaining compliance with applicable requirements, utilizing your skills and expertise in regulatory documentation, coordination, and compliance support. Your contributions will help ensure high-quality, compliant regulatory processes that support Zymo Research. The Regulatory Affairs Associate is an entry-level position for an individual committed to developing a career in Regulatory Affairs. The role supports Regulatory Affairs activities primarily for Zymo Research and may also support affiliated companies as business needs require, with training and guidance from experienced Regulatory Affairs personnel. Join us in making a meaningful impact!
Requirements
- Bachelor’s degree in a science or related discipline preferred.
- Entry-level candidates and recent graduates are encouraged to apply; prior Regulatory Affairs experience is not required.
- Demonstrated interest in developing a long-term career in Regulatory Affairs.
- Positive, collaborative, and professional attitude with a strong willingness to learn and contribute to the team.
- Demonstrates initiative, ownership, and willingness to take on new responsibilities and unfamiliar assignments as learning opportunities.
- Flexible and adaptable, with the ability to research and work through regulatory questions that may require interpretation, judgment, and guidance.
- Highly organized and efficient, with strong attention to detail, time management, and ability to prioritize multiple tasks.
- Ability to work independently when appropriate, use MS Office to organize information for reports and presentations, and handle confidential information with professional integrity.
Responsibilities
- Support company registrations and device listings in domestic (U.S.) and international markets
- Support preparation and maintenance of IVDD/IVDR technical documentation and registrations
- Support product registrations and regulatory submissions to FDA and other regulatory bodies including 510(k) submissions as applicable
- Research applicable regulations, standards, and guidance documents and summarize findings for review
- Assist with reviewing and writing SOPs and other Regulatory Affairs policies as necessary
- Coordinate with cross functional teams regarding product changes and regulatory notification and/or approval requirements
- Perform initial reviews of marketing materials, labels, and public communications for regulatory compliance under guidance
- Assist with evaluating product compliance with applicable regulations and project requirements
- Assist with and participate in notified body audits, ISO registrar audits, government inspections, customer audits, and other audits or regulatory activities as needed.
- Support Regulatory Affairs projects across Zymo Research and affiliated companies and perform other related duties as business needs require
Benefits
- Medical, Dental, Vision, and Life Insurance Coverages
- EAP Sessions
- Vacation Time plus Company Holidays
- Paid Sick Leave
- Generous 401(K) with matching
- Employee Referral Bonus
- Complimentary fruit, snacks, and beverages
- Complimentary catered lunches on Thursdays
- Complimentary EV Charging
- Cell phone stipend
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
