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X4 Life Sciences
Chelmsford, MA, United States
A small-scale medical device organization based in Chelmsford, MA that focus on plastic injection molding has focused their efforts on brining in a Manager of QARA on a full-time basis. This individual is expected to come in and lead the entire QARA team, incorporating responsibility for activities in which the company will uphold it's regulatory c
Job Source: X4 Life SciencesDanaher Corporation
Marlborough, MA, United States
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will
Job Source: Danaher CorporationCytiva
Marlborough, MA, United States
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will
Job Source: CytivaVigil Neuroscience
Watertown, MA, United States
Vigil Neuroscience is the worlds first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brains immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalitie
Job Source: Vigil NeuroscienceDanaher Corporation
Marlborough
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will b
Job Source: Danaher CorporationVigil Neuroscience
Watertown, MA, United States
Vigil Neuroscience is the worlds first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brains immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalitie
Job Source: Vigil NeuroscienceBostonGene
Waltham, MA, United States
Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular
Job Source: BostonGeneXilio Therapeutics
Watertown, MA, United States
Vice President, Regulatory Affairs and Quality Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its
Job Source: Xilio TherapeuticsChelmsford, MA, United States
A small-scale medical device organization based in Chelmsford, MA that focus on plastic injection molding has focused their efforts on brining in a Manager of QARA on a full-time basis.
This individual is expected to come in and lead the entire QARA team, incorporating responsibility for activities in which the company will uphold it's regulatory compliance.
The main responsibilities of the role are listed below but are not limited to:
Lead development, implementation and management of the QMS.
Work on PPAP requirements of customers, as well as implementing quality-based efforts to manufacturing and sterilization.
Smooth the way for external Quality System audits and guide the department through any upcoming FDA inspections.
Provide expertise on FDA submissions.
Spearhead the QARA department's work towards US and EU regulatory requirements.
Various levels of preferred experience is listed below:
5+ Years' of experience within the field of medical device or injection molding industries.
Preferred but not required would be any experience working amongst polymers, biology or metrology.
Experience in writing standard operating procedures and knowledge and experience working to international and state laws and regulations such as ISO 13485 & FDA QSMR.
Interested in learning more? Apply to Andrew Willoughby at X4 Life Sciences at [email protected]
Email Alert for Quality and Regulatory Manager jobs in Chelmsford, MA, United States
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