- Hologic (Marlborough, MA)
- …a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of ... in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO 14970, IEC 60601, IEC… more
- Takeda Pharmaceuticals (Boston, MA)
- …level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive ... regulatory submissions. + Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... quickly, efficiently and cost-effectively. Together, Teradyne (http://www.teradyne.com/) companies deliver manufacturing automation across industries and applications around the world!… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... quickly, efficiently and cost-effectively. Together, Teradyne (http://www.teradyne.com/) companies deliver manufacturing automation across industries and applications around the world!… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... quickly, efficiently and cost-effectively. Together, Teradyne (http://www.teradyne.com/) companies deliver manufacturing automation across industries and applications around the world!… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... quickly, efficiently and cost-effectively. Together, Teradyne (http://www.teradyne.com/) companies deliver manufacturing automation across industries and applications around the world!… more
- J&J Family of Companies (Danvers, MA)
- …engineering, computer science, or related field required + Strong knowledge of medical device regulations (FDA, MDR, etc.) required + Experience launching ... patient outcomes + 10+ years of experience in product development within the medical device or pharmaceutical industry + Proven experience in leadership roles… more
- Fujifilm (Boston, MA)
- …and advertising regulations and other regulations specific to Life Sciences/Pharma and Medical Device companies. + Perform other duties as assigned. **Required ... corporate law firm and/or in-house legal department, preferably in the Life Sciences/Pharma, Medical Device or health care field. + Solid commercial contract… more
- Teleflex (Chelmsford, MA)
- …and audit participation. A strong background in quality assurance within the medical device industry, along with excellent organizational and communication ... a manufacturing environment, with preference in a regulated or medical industry. *Critical thinker with a demonstrated exposure to compliance requirements.… more
- Philips (Cambridge, MA)
- …of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality/Control, ... working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards. + You have experience independently… more