Principal Regulatory Affairs Specialist
Company: Fresenius Kidney Care
Posted on: November 17, 2023
Principal Regulatory Affairs Specialist page is loaded Principal
Regulatory Affairs Specialist Apply locations Lawrence, MA, USA
time type Full time posted on Posted 2 Days Ago job requisition id
R0098780 Position Summary: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.Responsibilities:
- Develop regulatory strategies and plans for NxStage Medical,
- 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, and regulatory 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 &
- 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
- Maintain corporate regulatory files.Education & Qualifications:
- B.S. in technical discipline preferred or equivalent
- 8+ years' experience in domestic and international Regulatory
Affairs in the medical device industry
- Experience interacting with FDA regarding regulatory
- 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
plusEO/AA Employer: Minorities/Females/Veterans/Disability/Sexual
Orientation/Gender IdentityFresenius Medical Care North America
maintains a drug-free workplace in accordance with applicable
federal and state laws. EO/AA Employer:
Identity Fresenius Medical Care North America maintains a drug-free
workplace in accordance with applicable federal and state laws.
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Keywords: Fresenius Kidney Care, Lawrence , Principal Regulatory Affairs Specialist, Other , Lawrence, Massachusetts
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