- Hologic (Marlborough, MA)
- …input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, ... regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST,… more
- Evident Scientific (Needham, MA)
- …and US Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as ... Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident MIS)... lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications. + Ensure ongoing… more
- Oracle (Boston, MA)
- …all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's ... standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory... FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices.… more
- Hologic (Marlborough, MA)
- …communications, and health risk assessments. + Proven track record in implementing FDA and international regulatory requirements for recalls and market ... the coordination and execution of global field actions, ensuring compliance with regulatory requirements and maintaining the highest standards of quality and safety.… more
- Lilly (Boston, MA)
- …standards. _Regulatory Support Activities_ + Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory ... responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... US/EU + Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA , EMA, and others + Multiple NDA/MAA submission… more
- Abbott (Burlington, MA)
- …determine if a medical device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within ... regulatory requirements.Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating… more
- Globus Medical, Inc. (Methuen, MA)
- …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence to ... Development** + Collaborate with clinical experts, product managers, and regulatory teams to translate surgical workflow requirements into technical...Medical Image Processing is a plus + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA… more
- Sanofi Group (Framingham, MA)
- …CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, ... **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown,...+ Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators… more
- Hologic (Marlborough, MA)
- …for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact with internal ... quality through technical leadership, root cause analysis, and adherence to regulatory standards. You'll drive process and product improvements by analyzing… more