- Olympus Corporation of the Americas (Westborough, MA)
- …working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, ... leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of… more
- CGI Technologies and Solutions, Inc. (Boston, MA)
- …or TrackWise a plus). * Solid understanding of regulatory requirements and compliance standards ( FDA , EMA, etc.). * Excellent communication, facilitation, and ... will lead multiple workstreams, drive agile project delivery, and ensure compliance with regulatory standards. This role requires hands-on experience with Jira,… more
- Robert Half Technology (Boston, MA)
- …environments (on-premise, cloud, and virtualized infrastructure). * Maintain security protocols in compliance with FDA , HIPAA, and GxP standards. * Develop ... Ideal candidates will have a deep understanding of the biotech sector's compliance requirements and the agility to adapt to a fast-paced innovation-driven… more
- North Coast Seafoods (Boston, MA)
- …and maintenance work. + Safety & Compliance : Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- Takeda Pharmaceuticals (Boston, MA)
- …risks and regulatory requirements, such as the federal Anti-Kickback Statute, OIG Compliance Program Guidance, FDA legislation, FCPA, UK Bribery Act, etc., ... * Lead and conduct audits of Takeda's Non-GxP financial, operational, and compliance processes to evaluate Takeda's control environment within the Americas region… more
- Takeda Pharmaceuticals (Boston, MA)
- …you and empower you to shine? Join us as a Manager, Global Trade Compliance based in Cambridge/Lexington, MA reporting to the Senior Director - Global Clinical ... Supply Chain Import Export Operations and Global Trade Compliance . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market… more
- Wolters Kluwer (Waltham, MA)
- …and regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug control/ compliance programs, covered programs ... (Medicare/Medicaid) and other government drug-related policy and program information. * Have an in-depth understanding of drug classification systems, drug packaging attributes, drug clinical attributes, pricing and reimbursement data, and regulatory… more
- FleishmanHillard (Boston, MA)
- …Journalism, or a related field; Master's a plus. + Working knowledge of healthcare compliance requirements (eg, FDA , HIPAA, OPDP). + Strong grasp of digital ... measurement frameworks and how to connect performance data to storytelling impact. + A creative, strategic, and analytical mindset with a passion for health equity, innovation, and digital transformation. **Our Story** We're more motivated by what we can give… more
- Bristol Myers Squibb (Devens, MA)
- …with cross functional teams. + Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also ... This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This… more
- Integra LifeSciences (Braintree, MA)
- …possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance the ... matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate...software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven experience… more