||Regulatory Affairs Manager
The incumbent will manage the regulatory process, both domestic and international markets, for NxStage Medical, Inc. products and provide regulatory input into key quality system processes, such as design controls, change control, labeling and advertising and others. The incumbent may supervise regulatory staff.
• Develop regulatory strategies and plans for NxStage Medical, Inc. products.
• Prepare and submit US regulatory submissions including 510(k)’s, IDE’s, etc.
• Prepare and submit international regulatory submissions, as international market develops. This includes but is not limited to Canada, Europe (CE Mark), Mexico, Asia, etc.
• Communicate directly with senior management, economic operators, andregulatory agencies on all regulatory issues.
• Monitor regulations, guidance and standards and communicate applicable requirements to affected departments of NxStage.
• Determine impact of product and system changes on regulatory status for both US and OUS distributions.
• Prepare documentation to support no-filing decisions for US & International Markets.
• Participate on cross-functional developmental teams including project planning and design review activities.
• Participate in compliance related activities, including Quality System Audits, labeling reviews, and verification/validation reviews.
• Maintain corporate regulatory files.
• Prepare and maintain Device Listing, Establishment Registration. Etc.
||Education & Qualifications:
• B.S. in technical discipline preferred or equivalent experience.
• 8+ years experience in domestic and international Regulatory Affairs in the medical device industry including managing of regulatory staff.
• Experience interacting with FDA regarding regulatory matters
• Expertise in working within Medical Device Regulations including Quality System Regulation 21 CFR Part 820, ISO 13485, EU MDD/MDR, Canadian Regulations
• Experience in product development of medical devices a plus
• Experience in drug regulations and submission a plus
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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