Position Summary
The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists as part of the role.
Principal Responsibilities
• Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the US, EU and Canada for new and modified products.
• Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments.
• Communicate with Commercial RA to ensure timely notification of changes as appropriate. Partner with Commercial RA to support registration of product in foreign markets.
• Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.
• Interact and negotiate with regulatory authorities during the development (i.e. Q-Sub, change notifications, etc.) and submission review.
• Support regulatory agency and/or notified body audits by as needed.
• Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
• Participate in development and approval of risk activities as well as other deliverables as related to projects.
• Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.).
• Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated.
• Assist in regulatory due diligence process as needed.
• Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.
• Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Comply with company Code of Ethics, all Company policies, rules, and procedures.
Education / Experience Requirements
• Bachelor’s degree in a science or engineering field, or equivalent work experience.
• 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of experience with Class I, II or III medical devices.
• Proven history of successful domestic and/or international submissions.
Specialized Skills / Other Requirements
• Strong analytical and critical thinking skills.
• Strong verbal and writing communication skills.
• Ability to manage and prioritize multiple projects to meet deadlines that align with the BU’s objectives.
• Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.
• Proficiency in MS Office software programs
• RAC certification is a plus.
About URBAN REVIVO URBAN REVIVO, a fashion brand under the FMG Group, is a dynamic global fashion brand specializing in trendy, affordable apparel and accessories. With a focus on fast fashion and innovative designs, we empower individuals to express their unique style...
...strategic Cybersecurity Communications Manager to transform complex security information into clear, actionable communications that enable... ...processes WHAT YOU'LL BRING: Experience in internal communications supporting business executives and translating technical...
...join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.**The Manager, Anatomical Pathology, directs the daily operations of the anatomic pathology laboratory. Oversees budgeting, staffing, training, and performance management...
The Facility Operations / ASC Technician is responsible for maintaining and supporting the physical environment, equipment, and infrastructure of the ambulatory surgery center. This role ensures that the facility is safe, clean, functional, and fully equipped to support...
...Service & Technical Support Representatives. This is a fully remote role supporting a 365-day, 24/7 call center . Recent... ...calm with upset or frustrated customers ~ Willing to work overnights, weekends, and rotating schedules in a 24/7 environment ~ Must live...