Regulatory Affairs Specialist

Company Name:

Henry Schein Orthodontics

Job Location:

Carlsbad, CA

Position Title:

Regulatory Affairs Specialist

Position Type:

Full time


· Prepare and submit registration dossiers to ensure compliance with the FDA, Health Canada, EU Competent Authorities, etc., for timely registration approvals.

· Create, review and maintain CE Technical Files and make appropriate submittals to the EU Representative and Notified Body to ensure compliance with the Medical Device Directive and Medical Device regulation.

· Provide guidance, review and approval of promotional and advertising materials, product claims, training materials, Instructions for Use, labels and other related labeling to ensure compliance with regulations.

· Assist with post market surveillance activities, i.e., adverse event reporting and field corrective actions.

· Create, maintain and ensure accuracy of regulatory documentation, including but not limited to: 1) MAUDE Post Market Surveillance and 2) CER's for branded products at required intervals.

· Represent RA in New Product Meetings to establish regulatory strategy, classification, hazard class and regulatory applications, as required.

· Review and implement change requests and notifications as they impact regulatory documentation.

· Work cross functionally to ensure timely submission of international requests.

· Participate in meetings with regulatory agencies when required.

· Support the preparation of Audit documentation when required.

· Assist in authoring department reports to ensure internal metrics are met.

· Stay current on applicable FDA, ISO (including risk management) and other applicable industry requirements.

· Participate in special projects and performs other duties as required.


· Ability to effectively problem solve through critical thinking and root cause analysis with

· Minimal direction and make decisions with confidence

· Excellent organizational skills and attention to detail

· Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.)

· Ability to prioritize, multitask and adapt to change

· Ability to work within budget constraints and to work with minimal guidance to perform job function

· Ability to respond in a timely manner to inquiries and complaints from regulatory agencies

· Word processing skills, including Microsoft Word, Excel, and PowerPoint

Education and Experience

·Four-year degree in sciences or health related field with 2-4 years related experience; OR 5 -7 years prior experience as a Regulatory Affairs Specialist in a medical device regulated facility.

· Hands on experience with international registrations a must, preferably in the dental device industry.

Application Information & Contact (How to Apply)

Please apply by visiting the job portal and searching for 'regulatory affairs' in the keywords section.

Learn more about Henry Schein Orthodontics here.

SDRAN Address

P.O. Box 927595
San Diego, CA 92192-7595


Contact us

Join us on:


  • LinkedIn Social Icon

© 2016 SDRAN