Regulatory Affairs Specialist

** Regulatory Affairs Specialist A global leader in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. This position is perfect for a candidate with strong communication and problem-solving skills who is passionate about advancing medical technology. This is a great opportunity to join a cutting-edge organization and play a key role in shaping regulatory strategy and supporting innovative product development.The Regulatory Affairs Specialist should have the following **Bachelors or masters degree in engineering or a technical field3+ years of regulatory affairs experience in the medical device industryProven track record with successful 510(k) submissionsWillingness to work on-site at our Pennsylvania locationAbility to work effectively with cross-functional and risk management teamsResponsibilities of the Regulatory Affairs Specialist ****Provide regulatory support for medical device projects from development through post-market stagesCoordinate and prepare global regulatory submission documents with cross-functional inputDevelop and maintain procedures and work instructions to ensure ongoing regulatory complianceCollaborate closely with product development teams to implement global regulatory strategiesMonitor changes in regulatory requirements and communicate potential impacts to internal stakeholders

Created: 2025-06-09