48 results for Regulatory Manager Jobs in Waltham, MA, US

Lead and execute CMC regulatory activities for clinical drug development, generate compliant regulatory submissions, provide guidance on regulatory content, review documentation, communicate with regulatory Health Authorities, and ensure alignment with current regulations.

Regulatory Affairs ManagerX4 are partnered with a highly regarded global medical device company known for its leadership in developing advanced technology that addresses serious medical conditions with precision and efficiency. Their commitment to excellence ensures that life-saving treatments are a...

Job TitleRegulatory Affairs Program ManagerJob DescriptionThe Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting effic...

About The JobThe Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, thedevelopment of regulatory strategy, and contributing the regulatory approval process (including US FDAand other regulatory authorities) for FMI products. The incumbent functions a...

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves sur...

Position Overview:We are seeking a seasoned Market Regulatory Affairs Manager to lead and evolve our post-market regulatory affairs team supporting hemostasis and acute care diagnostic products, including GEM product lines. This is a high-impact, high-visibility leadership role responsible for overs...

Responsible for managing regulatory submissions and developing regulatory strategies for in vitro companion diagnostic medical devices. Interfaces with the FDA, reviews technical documents, and ensures compliance with regulatory requirements. Supports product development teams and mentors junior tea...

Job Title: Research and Development Regulatory Affairs ManagerReports To: Vice President - Research and DevelopmentSUMMARYThe Manager, Regulatory Affairs is responsible for regulatory compliance and label accuracy for all products. This person should be experienced in interpreting regulations and im...

Company Overview:Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.Our mission to deliver innovative, life-savin...

Be Seen and Heard at EyePoint PharmaceuticalsAt EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary p...