What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist I position at Align Technology?
Description
Role expectations
What we're looking for
The Sr. Regulatory Affairs Specialist I will be responsible for regulatory activities for Software as Medical Device (SaMD) registrations and maintenance of sustaining product. In addition, this role will be a global RA lead in product development cross functional team to lead global regulatory strategy, global regulatory assessment for changes, and support International registrations working with international RA affiliates. This role leads preparation of US, EU and Canada submissions for regulatory approvals. This position also supports post market regulatory activities including regulatory operations and compliance, such as UDI, Non-Conformance, audit support, and process improvement.
Role expectations
- Lead 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
- Leads and prepares regulatory submissions, technical documentation, and associated documents for registrations in the US, Canada, EU and UK.
- 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
- Be an RA SME in certain area as assigned, e.g., software, AI/ML, to provide requirement interpretive assistance or advise on solution for issue.
- 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.
What we're looking for
- Minimum 4 years of technical experience including at least 3 years of regulatory experience in a medical device industry.
- Bachelors Degree in a related technical or science field. Masters degree in life sciences or technical field is preferred
- Experience with EU MDR Technical Files.
- Experience with SaMD and/or AI/ML is preferred.
Skills:
- Proficiency in Microsoft Office applications
- 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
- Strong analysis, organizational, follow-up skills, as well as attention to detail.
- Exercises good judgement to research, analyze, evaluate, plan and solutioning, and execution to deliver results or resolve issues. Being able to drive, coordinate with stakeholders and activities to analyze issues, situation and come up solution.
- Communication: Strong written and verbal communication skills with ability to effectively communicate at multiple levels in the organizatioTeamwork: 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.
