Regulatory Affairs Specialist

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. The position will prepare product submissions, license renewals, periodic updates and registrations to regulatory agencies.

You will:

• Represent Regulatory affairs on R&D product development project teams. Ensures all regulatory affairs deliverables are planned and provided to the project team in a timely manner.
• Participate in the writing of documentation required for regulatory submissions.
• Maintain technical documentation to current revisions.
• Provide regulatory review/approval of OrthAlign documents, products, and processes for regulatory compliance and assesses requirements for reporting changes to regulatory agencies or commercial partners.
• Support product registration and post-approval activities as assigned. Maintain regulatory files/databases in good order.
• Support recall activity.
• Participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC and R&D departments and senior management as required.
• Evaluate each complaint for medical device reportability and file required medical device reports/follow ups in a timely manner.

You need:

• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software
• Demonstrates excellent written and verbal communication skills
• Results-oriented with appropriate urgency
• Self-motivated with the ability to work as a collaborative team member as well as independently
• Excellent attention to detail, producing high quality output
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Applies sound judgment when making decisions and communicating with internal and external customers
• Maintains current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Understand the job specific quality system procedures and processes and adhere to the requirements of those documents
• Maintains corporate confidentiality at all times
• Knowledge of US and international medical device regulatory requirements
• International experience is required
• Experience with EU Class I devices and FDA Class II devices is desired

We offer:

• Competitive compensation including bonus and equity
• Opportunities for career advancement
• Full benefits package
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.

No recruiters, please.