| Job alert | Jobs 61 - 70 of 660 |
Head of Regulatory Affairs
Discera Search
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Boston, MA, 02298
... Demonstrate resilience and assertiveness in interactions with the FDA, advocating for our innovative therapies and proactively addressing regulatory challenges to ensure timely approval and market access. Facilitate communication with the FDA, ... - May 01
Sr. Associate Compliance
Sun Pharmaceutical Industries
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Billerica, MA, 01821
... Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, ... - May 07
Medical Device Test Engineer
Cytrellis Biosystems
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Woburn, MA, 01801
... What makes Cytrellis different: ️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. ️ Untapped Market Potential: 5x account growth in the last 8 months ️Voted Best Non ... - May 14
Sr. Associate, Compliance
Sun Pharmaceutical Industries
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Billerica, MA, 01821
... Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents. Risk Management aspects ... - May 07
Engineer: Process Improvement Engineer
Nanobiosym
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Cambridge, MA
... Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team with details of root cause analysis. ... - May 14
Research Analyst
ERG
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Concord, MA
... Department of Health and Human Services (HHS), Massachusetts Department of Public Health (DPH), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and others. The ... - May 09
Software Test Engineer
The Davis Companies
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Nashua, NH, 03062
... Ensure adherence to regulatory standards, including FDA guidelines, and IEC 62304, and KMC Quality Procedures throughout the software development lifecycle. Required Bachelor's or master’s degree in CS or related degrees. Minimum of 3+ years with a ... - Apr 26
Design Quality Engineer 2
J&J Family of Companies
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Danvers, MA
... and validation test plans, protocols and reports * Ensure that Design controls are compliant with all relevant regulations (FDA, ISO13485, EU MDR, PMDA) * Lead, conduct and own risk management activities including Hazard Analysis, System Risk ... - May 10
QA Compliance Specialist
Actalent
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Bedford, MA, 01730
Description: * Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will ... - May 07
Manufacturing Manager
Transmedics, Inc.
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Lawrence, MA, 01812
... Strong knowledge of medical device regulations (FDA, ISO 13485, etc.). Demonstrated leadership and team management skills. Excellent problem-solving and decision-making abilities. Effective communication and collaboration skills. Familiarity with ... - May 15