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.
...accepting applications for the full-time position of Admissions Counselor to join our hardworking, dynamic, and supportive team. This... ...through engagement with moves management. Develop and maintain a travel schedule pertaining to college fairs and high school visits....
...SENIOR ESTIMATOR JOB ID: 24067 LOCATION: Richland, MS Our client is looking for a Senior Estimator who will lead cost estimating for large electrical infrastructure projects. Youll prepare competitive bids, mentor junior estimators, and collaborate with project...
...Position Summary The Program Manager, Membership is responsible for developing, optimizing, and expanding membership programs that drive engagement, retention, and long-term value for both corporate and individual members. This role serves as a strategic partner to internal...
...engineering, and other materials testing services for a wide array of private and public sector clients. We are looking to hire a Dispatcher to work in our Natick office. Responsibilities Communicating with project team and inspectors to create synergy....
We are currently seeking an experienced AP Specialist / Junior Accountant to fill an opening with a client local to the Atlanta market. This role is ideal for an accounting professional with 12 years of corporate accounting experience who is looking to continue building...