- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
- Danaher Corporation (Putnam, CT)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adequate support at global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part of due diligence and ... is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. +...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Wolters Kluwer (Waltham, MA)
- …device software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including surveillance, ... potential business/ regulatory risks; communicate risks and lead implementation of regulatory measures. + Evaluate global regulatory landscape and… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to… more
- ThermoFisher Scientific (Waltham, MA)
- …Fisher as a leader in the CRO industry and was one of the largest global transactions in 2021. Other transactions spanned the scope of our entire business including ... + Manage the external and internal legal teams responsible for the legal affairs relating to Corporate Development, M&A and Strategic Capital in an efficient and… more
- Curia (Hopkinton, MA)
- …to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs + Acts as a key point of contact with customers ... quality leadership and drives Quality decisions at the site and also supports regional Director of Quality for global Quality initiatives + Provides hands on… more