Senior Regulatory Affairs Specialist

OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior 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.  In this role, you will prepare product submissions, handle license renewals, and provide periodic updates and registrations to regulatory agencies. This job works from our Home Office in California, and is not remote.  We are excited to announce that we will be moving to Irvine, near the 5 and 133 interchange, in early April.

You will:

• Represent Regulatory Affairs on R&D product development teams to ensure all regulatory requirements are communicated and met throughout the product development process

• Provide insight into regulatory standards products must meet, test method requirements, and the body of evidence required for US and OUS regulatory submissions

• Complete submissions to FDA, EU, and other regulatory agencies

• Actively participate in the evaluation for regulatory compliance of documents, products, and processes and test methods

• Review labeling and labels for compliance to regulatory standards and to regulatory submissions

• Provide regulatory reviews of customer complaints, define regulatory reportability, and complete reports as required

• Prepare periodic risk assessment and post market surveillance summary documentation

• Prepare input data to periodic clinical evaluation reports

• Prepare materials for license renewals, updates, and registrations in a timely manner

You need:

• BS/BA degree

• 4+ years in medical device regulatory affairs, FDA 510(k) Class II orthopedic experience strongly desired, and EU MDR Class I orthopedic devices preferred

• Understanding of current FDA and International regulations, guidance and standards applicable to medical device products

• Ability to maintain corporate confidentiality at all times

• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)

• Excellent written and verbal communication skills

• Results-oriented with appropriate follow-up to issues

• Ability to work as a collaborative team member as well as independently supervision

• Excellent attention to detail, producing high quality output

• Flexibility and strong organizational skills with ability to prioritize multiple tasks

• Strong interpersonal relationship skills including negotiating and relationship management

• Ability to apply sound judgment when making decisions and communicating with internal and external customers

We offer:

• Competitive compensation including bonus and equity

• Opportunities for career advancement

• Full benefits package

• An evolving, engaging culture and workspace

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

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