Senior Regulatory Affairs Specialist, NxStage Medical, Inc., a Fresenius Medical Care N.A. company, Lexington, Massachusetts (Remote)

Responsible for working on the regulatory process in both domestic and international markets for NxStage Medical, Inc. products. Will provide regulatory input into key quality system processes such as Design Reviews and Engineering Change Orders. Specific duties include:

• Prepares and submits US regulatory submissions including 510(k)s, IDEs, and pre-submissions.
• Prepares and submits international regulatory submissions, including but not limited to Canada and Europe (CE Mark).
• Prepares documentation to support “No Filing” decisions for US & international markets.
• Participates in cross-functional developmental teams and their activities including project planning and design review activities.
• Reviews and approves Engineering Change Orders in accordance with regulatory requirements.
• Participates in compliance related activities, including quality system audits, labeling reviews, and verification/validation reviews.
• Reviews advertising and promotional documents for compliance with applicable regulations.
• Maintains corporate regulatory files including EU technical files/documentation (Medical Device Directives & Medical Device Regulations).
• Prepares and maintains UDI Records and Baseline Reports.

Requirements:
Position requires either (i) a Bachelor’s degree (or equivalent foreign degree) in Regulatory Affairs or a closely related field and 5 years of experience as a Regulatory Affairs Specialist in the medical device field or (ii) a Master’s degree (or equivalent foreign degree) in Regulatory Affairs or a closely related field and 3 years of experience as a Regulatory Affairs Specialist in the medical device field.

Must also have 3 years of experience (which can have been gained concurrently with either primary experience requirements above) with the following:

• Aiding in regulatory strategies for both domestic and international regulatory submissions;
• Preparing 510(k) submissions, IDE reports, and technical documentation for EU Notified Body submissions;
• Working with ISO13485 and FDA Quality Management System requirements (QSR);
• Participating in Internal and External audits;
• Working cross-functionally with labeling and technical teams and reviewing advertising and promotional materials; and
• Reviewing and approving Engineering Change Orders and maintaining UDI records.

This is a telecommuting position working from home. May reside anywhere in the United States.

• Prepares and submits US regulatory submissions including 510(k)s, IDEs, and pre-submissions.
• Prepares and submits international regulatory submissions, including but not limited to Canada and Europe (CE Mark).
• Prepares documentation to support “No Filing” decisions for US & international markets.
• Participates in cross-functional developmental teams and their activities including project planning and design review activities.
• Reviews and approves Engineering Change Orders in accordance with regulatory requirements.
• Participates in compliance related activities, including quality system audits, labeling reviews, and verification/validation reviews.
• Reviews advertising and promotional documents for compliance with applicable regulations.
• Maintains corporate regulatory files including EU technical files/documentation (Medical Device Directives & Medical Device Regulations).
• Prepares and maintains UDI Records and Baseline Reports