- AbbVie (Worcester, MA)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA, EMA and MHRA requirements. This role bridges the… more
- ThermoFisher Scientific (Boston, MA)
- …organizational expertise, and **_deep industry knowledge across the pharmaceutical, biotech, or medical device sectors_** , along with a proven track record ... key account management in a related Pharmaceutical, Biotech or Medical Device sales industry + Experience in...common customer needs in this field. + Awareness of regulatory landscape, including understanding regulatory bodies, compliance… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs. + Advanced knowledge ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more
- Integra LifeSciences (Braintree, MA)
- …mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product ... related discipline, with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years… more
- Insight Global (Bedford, MA)
- … submissions, complaint systems, and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR) and standards (eg, ... that design control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required procedures, standards, and regulations.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of the typical functional roles and responsibilities in medical device organizations. + Practical understanding of global regulatory /quality standards and ... 7 years of experience in a cross-functional project leadership role in the medical device industry, preferably leading due diligence and post-merger integration… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Candela Corporation (Marlborough, MA)
- …activities in an FDA regulated environment that meets internal quality requirements and regulatory standards for Class I/II medical devices (FDA 21 DFR 820.30, ... **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global… more
- J&J Family of Companies (Danvers, MA)
- …of role responsibilities **Preferred Qualifications:** + Master of Science degree + Medical Device product development experience + Knowledge in medical ... + Apply biomedical, mechanical, and electrical engineering principles to develop medical devices (Impella pump and system). + Lead and contribute to… more
- Guidehouse (Boston, MA)
- …Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle ... provides commercialization strategy and reimbursement services to pharmaceutical, biotechnology, medical device , and diagnostics companies. Our client services… more