Regulatory Affairs Specialist

Regulatory Affairs Specialist

Department: Quality

Employment Type: Full Time

Location: US-North Carolina-Raleigh

The Regulatory Affairs Specialist will be responsible for a wide variety of regulatory activities for sustaining products including medical devices and Software as Medical Device (SaMD) and regulatory operation. In addition, this role will be a global RA lead in product development cross functional team to lead global regulatory assessment for changes and support International registrations working with international RA affiliates.

This role will assist or lead preparation of US, EU and Canada submissions for regulatory approvals, and license maintenance. This position also supports post market regulatory activities including regulatory operations and compliance, such as UDI, Non-Conformance, audit support, and process improvement.

• Lead or assist development and implementation of global regulatory strategy or product change impact assessment for Class I/II products in US, Canada, EU, UK, and support international regulatory assessment and registrations. Liaison between Align International RA affiliates and core functional team to provide global perspective. Reviews documents or engages in discussions to support international registrations
• Lead or assist preparation of regulatory submissions, technical documentation, and associated documents for registrations or license maintenance in the US, Canada, EU and UK.
• Assist regulatory operation to ensure regulatory compliance for audit readiness
• Collaborate with cross functional team or business partners to provide regulatory input to product lifecycle planning. Review product development documentation, labeling, claims and advertising promotional materials to ensure regulatory compliance or successful registrations.
• Regulatory liaison/representative in internal or external audits
• Keeps abreast of existing and emerging regulations, standards, and guidance documents related to Align products. May conduct impact assessment, or interpretive assistance.
• Compiles and maintains regulatory documentation databases and tracking systems as necessary
• May lead Regulatory initiatives to improve efficiency or address gaps in process
• May support regulatory compliance or operation activities, including but not limited to recall, Non-Conformance, CAPA, audit, process improvement, country approval, distribution control, annual update, post market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.

• Education:
  
  Bachelors Degree in a related technical, science or legal field. Masters degree in related field is preferred

• At least 2 years of regulatory experience in a medical device industry.
• Experience with EU MDR Technical Files and Design Control

• Skillful in computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint, PDF
• Skill or knowledge of applying AI tool in regulatory
• Solid understanding of Design Control requirements, FDA QSR regulations, and ISO 13485 MDSAP quality System Management
• Keen ability to prioritize work and execute in an environment of competing priorities. Excellent time and project management skills with the ability to multi-task
• Communication:
  Strong written and verbal communication skills with ability to effectively communicate at multiple levels in the organization
• Strong organizational, follow-up skills, as well as attention to detail.
• Being able to drive, coordinate with stakeholders and activities for tasks execution to deliver results, analyze or resolve issues
• Teamwork:
  Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team. Ability to work within a team and as an individual contributor in a fast-paced, changing environment

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the…