May 13, 2022

Regulatory Affairs Specialist

  • Sprig Oral Health Technologies, Inc
  • Loomis, CA, USA
Full time Biotech Manufacturing Regulatory

Job Description

Sprig Oral Health Technologies, Inc.

Join our Amazing Team!

Sprig Oral Health Technologies, Inc is an innovative and evolving medical device company that is making a positive difference in the field of pediatric dentistry.  Apply online at www.sprigusa.com and go to “careers” link at the bottom of the website.

We Offer:

  • Friendly and fun company culture!  
  • Full benefit package including Medical, Dental, Vision, and Life Insurance 
  • Competitive salary offered that aligns with the market for this type of position
  • EAP (Employee Assistance Plan offering FREE mental health services)
  • 2 weeks paid vacation per year
  • 401(k) with company match
  • 9 Paid Holidays
  • Wellness program
  • Tuition Reimbursement, Professional Development and Career Advancement Opportunities
  • Located in Loomis, CA, we offer convenient and free, onsite parking.  Our jobsite is also within easy walking distance to many conveniences including Starbucks, Raley’s, restaurants, and other local businesses.  

Job Summary

  • The Regulatory Affairs Specialist is responsible for providing support for internal, external, and regulatory agency audits and works to ensure compliance with Sprig products, procedures, ISO standards, and regulatory bodies.
  • Responsible for assisting with compiling, submitting, and maintaining appropriate technical documents and applications for regulatory submissions for medical devices.
  • Collaborates with the RA/QA team to ensure the completion of the regulatory process for products requiring governmental approval by following established timelines to meet corporate objectives.
  • To be successful in this role, you are adaptable to an evolving and dynamic workplace. You have great organizational and time management skills. 

Position Type/Expected Hours of Work:

Monday – Friday, Daytime Hours.  Office location is in Loomis, Ca.

Requirements for this position:

  • Bachelors degree in a scientific or engineering field.
  • Minimum of five (5) years experience in Quality Assurance or Regulatory Affairs.
  • Experience with ISO 13485, FDA QSR, MDD/MDR-CE Mark.
  • Have a thorough knowledge of Quality Systems auditing principles and practices.
  • Experience with medical device product registrations.
  • Excellent communication, verbal, and writing skills. Strong attention to detail.
  • Excellent computer skills including experience with full MS Office, ERP/MRP systems, Visio or SmartDraw, SharePoint, Document and Configuration Management, Business Process Management workflows, etc.
  • Experience handling external and internal audits (Notified Bodies, Regulatory Agencies).
  • Ability to work independently and in a team environment.
  • Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.

Quality Management

Regulatory

Medical Device

ISO 13485


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