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Boston Scientific Regulatory Affairs Specialist II United States, Minnesota, Maple Grove
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written...
Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products. In conjunction with Clinical Research, support the preparation...
Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new...
Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed....
Leading and managing a functional interaction and engagement with the Magellan Project, typically collaborating with team leads / product owners. Aligning on requirements and influencing the Magellan Development Teams to...
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives. Create comprehensive regulatory strategies. Develop and...
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written...
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written...
Are you looking for a way to make a difference in the tech industry? Consider a rewarding and challenging career as a regulatory affairs specialist! These professionals play an essential role in getting new technologies approved and accepted into the marketplace.
The primary responsibility of a regulatory affairs specialist is to ensure that proposed products and services comply with applicable standards, regulations and guidelines. This may involve researching existing regulations, working on technical documents, and coordinating with regulatory bodies during the submission and review process. Regulatory affairs specialists must have a thorough understanding of relevant regulatory authorities and relevant industrial regulations.
Regulatory affairs specialists must demonstrate excellent attention to detail, problem-solving and communication skills, in addition to excellent technical knowledge. The ability to interpret large amounts of technical data and write clear reports and documents is essential. Regulatory affairs specialist must be comfortable working independently and collaboratively in fast-paced and dynamic environments.
At Expoint, you'll find numerous opportunities for regulatory affairs specialists, ranging from entry-level positions to managerial roles. As a regulatory affairs specialist, you'll gain valuable experience and insight into the tech industry, all while working with motivated colleagues and discovering new, cutting-edge technologies. If you're detail-oriented, have great communication skills and an interest in the tech industry, consider a career as a regulatory affairs specialist.