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.
...and collaboration skills. Preferred Qualifications: Experience working on commercial or military vessel programs. Familiarity with U.S. Navy or offshore vessel standards. Associates degree or technical diploma in drafting/design or a related field....
...Paralegal Certificate is strongly preferred; RP or CP certification or college degree preferred. ~ Significant experience using eDiscovery case management software. ~ Exceptional organization and project management skills. ~ Prior experience in litigation state...
...notre esprit dentreprendre ! KLB Group is hiring: Project Buyer Construction / Industrial Renovation Los Angeles The Role... ...to impactful, technical projects Flexible work arrangements (remote possible after initial onboarding phase) A supportive and...
** US Citizenship is required for this position. We are unable to hire individuals currently on a work visa or individuals who will require a work visa in the future. ** Job Summary: We are seeking a Senior Software Engineer to join our multidisciplinary team responsible...
...future of technology in artificial intelligence and cybersecurity, is looking for an experienced and motivated individual to fill their remote Senior Procurement Specialist role in McLean, VA. You will be apart of an expanding team and tasked with the ability to provide...