- Tecomet (Woburn, MA)
- … Regulatory Affairs, or a related field, or equivalent work experience in the medical device industry; + 5+ years of experience in quality assurance and ... regulatory affairs within a regulated industry ( medical devices preferred); **WORK ENVIRONMENT / PHYSICAL DEMANDS:** + Typical office environment with routine use… more
- United Therapeutics (Boston, MA)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Trinity Health (Springfield, MA)
- …time **Shift:** Day Shift **Description:** Come join the Plant Operations team at Mercy Medical Center, part of Trinity Health Of New England! We are a member of ... rosters, etc. + Assists the Director with Joint Commission and other regulatory compliance, documentation, and other related regulatory duties. Supports all… more
- Capgemini (Burlington, MA)
- …of cybersecurity and data privacy in medical systems. . Familiarity with medical device standards and regulatory requirements. . Proficiency in scripting ... strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: Develop and execute… more
- Medtronic (Boston, MA)
- …understanding of regulatory requirements and industry standards governing medical device reprocessing. + Excellent communication, interpersonal, and ... instrumentation. Commitment to upholding the highest standards of safety and quality in medical device reprocessing. + This position is in the east coast of US… more
- Abbott (Burlington, MA)
- …various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global ... + 5 years related work experience **Preferred Qualifications** + 3+ years in MDR ( Medical Device Reporting) + Knowledge of the use, development, and … more
- Sanofi Group (Cambridge, MA)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... market auto-injectors, pens, safety syringes, as well as connected medical device technologies, and we are gearing...validation plan and execution of IQ/OQ/PQ in accordance with regulatory , company & site requirements. Will often support sites… more
- Stryker (Boston, MA)
- …candidate resides in the territory area. + Minimum of three (3) years; in medical device clinical capacity or cath lab. + Proven understanding of cardiovascular ... new device development + Document procedural case observations for regulatory requirements and ongoing continuous improvement + Provide basic ultrasound training… more
- Jabil (Clinton, MA)
- … device product development environment, command of medical device design controls and related regulatory requirements, a penchant for maintaining ... the product lifecycle to enable both the growth and maintenance of our medical device product portfolio. Primary responsibilities of the role include user… more
- Integra LifeSciences (Boston, MA)
- …experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance, or other cGMP regulated ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing… more