- Merck (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on ... development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture… more
- Merck (Rahway, NJ)
- …**J** **ob description** This position will be responsible for leading and implementing medical device and combination product design controls for both new ... a culture of operational excellence + Ensure processes align with regulatory requirements for medical device and drug combination products (eg, FDA 21 CFR Part… more
- Sargent & Lundy (Hamilton, NJ)
- …you will be responsible for proactively guiding the business related to FACTS device standards, codes, designs and other related topics. You will advise the business ... + You will be responsible for guiding and mentoring junior and senior -level engineers and designers in FACTS engineering design efforts, including providing guidance… more
- J&J Family of Companies (Somerville, NJ)
- …facilitating meetings with stakeholders from multiple functions + Experience in the medical device , pharmaceutical or other highly regulated industry preferred. ... of America **Job Description:** Johnson & Johnson is currently recruiting for Senior QS Field Action Coordinator! This position can be located at any US J&J… more
- Pentax Medical (Montvale, NJ)
- …Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical device leader that is preparing for high growth. This means that ... play a crucial role in shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs...+ Bachelor's degree in Life Sciences or a related field (Masters preferred) + Three-five years' experience in Regulatory… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... **Position Overview** The Senior Upgrade Engineer is responsible for performing upgrades...for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In… more
- Integra LifeSciences (Princeton, NJ)
- …teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA Supplements,361 HCT/Ps, ... patient outcomes and set new standards of care. The Senior Regulatory Affairs Specialist is a seasoned senior...and international dossier submissions; Experience with medical device , biologic or implantable products is… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Sound knowledge of material science and engineering principles + Working experience in medical device industry + Familiar with design control process and ... **Job Description Summary** The R&D Senior Scientist reports directly to the Senior R&D...medical device regulations + Knowledge of method validation and… more
- Integra LifeSciences (Princeton, NJ)
- …or pharmaceutical sector. + Related quality/operations GMP work experience in a medical device or pharmaceutical manufacturing site or an equivalent combination ... outcomes and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead, coordinate and perform...assets. + Conducting supplier / regulatory compliance audits at medical device and/or pharmaceutical companies with a… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development of global regulatory ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent Regulatory...influencing skills. + Current knowledge of US and European medical device regulations. + Strong technical writing… more