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.
- 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.
- 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.