Regulatory Affairs Specialist

Company Name:

Henry Schein Orthodontics

Job Location:

Carlsbad, CA

Position Title:

Regulatory Affairs Specialist

Position Type:

Full time

Responsibilities:

· 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.

Qualifications:

· 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.

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