Job Title
Principal Regulatory Affairs Specialist
Job Description
Job title:
Principal RA Specialist
Your role:
- The Principal Regulatory Specialists will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.
- Author 510k submissions, led pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications and lead interactions with regulators/competent authorities throughout review and approval process.
- Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development.
- Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across spectrum of product lines.
- Monitor global regulatory landscapes and guide cross-functional team on implementation of regulation changes.
- Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
- Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory subject matter expert.
- Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
- Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate on process improvement teams to affect changes at a local or cross business unit level.
- Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance.
You’re the right fit if:
- Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience 510(k) experience is preferred.
- Preferred candidate will have a master’s degree in engineering or regulatory affairs or a related field with minimum of 7 years of experience. Will consider applicants Bachelors’ Degree with demonstrated experience working within Medical Device industry.
- Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentations and global registrations
- Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision.
- Solution and detail oriented, well organized and self-motivated with ability to negotiate with regulators.
- May require up to 20% travel