Manager, Regulatory Affairs Salary at Osram Sylvania Inc BETA

Job Advertisement: Regulatory Affairs Manager Location: Boston, MA (3 days a week in the office) Company: Confidential (Stealth-mode startup environment) Salary: $150,000 - $180,000 (including equity) About Us: We are a dynamic startup focused on developing innovative diagnostic tools for healthcare. Our mission is to leverage advanced technology to provide non-invasive, dignified, and actionable diagnostic solutions for healthcare. Position Overview: We are seeking a hands-on Regulatory Affairs Manager with a strong background in medical devices, particularly SaMD (Software as a Medical Device). This role is crucial for ensuring our products meet all regulatory requirements and standards. You will be responsible for managing regulatory submissions, maintaining compliance, and supporting the growth of our regulatory team. Key Responsibilities: Create and maintain 510(k) and De Novo submissions. Manage ISO and FDA audits. Prepare and update documentation for EU MDR conformity. Collect,

Help us make a difference! At Sunbird Bio, we’re developing protein-based diagnostic tests that provide unprecedented insights to enable earlier, more accurate diagnosis and treatment of Alzheimer’s disease and other neurological disorders. We are addressing the tremendous, growing need for more reliable and sensitive diagnostic tests to accelerate drug development and enhance patient care. We will be able to give patients and clinicians the clarity they need to make confident decisions when they matter most. Join our team to find a purpose-driven career and environment that supports you while you’re working to help others. About the job We are seeking an Associate Director level candidate with a track record of research excellence and diagnostic product development experience to join our R&D team. Expertise and knowledge of recent scientific and technological advances in immunodiagnostics is desired. The ideal candidate will be a highly motivated individual who leads from the bench an

Location: Cambridge, MA (Onsite) Science: Small Molecule Therapeutics Job Overview: The Associate Director in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners. Primary Job Responsibilities: Develop specialized testing methodologies for small molecule drugs using HPLC and GC. Oversee impurity characterization and stability studies for drug substances and products, ensuring regulatory compliance. Manage analytical testing and development activities with external partners to keep projects on schedule. Collaborate on CMC, quality processes and regulatory submissions, providing internal and external project alignment. Primary Job Requirements: PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product Expertise in method development for small-molecule drugs, with broad analytical expertise including HPLC, GC, MS, and NMR techniq

Senior Manager, Regulatory Affairs - CMC Location: Boston, MA USA Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to support the global development and approval of our innovative therapies. Responsibilities: The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals. Oversee the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents. Lead and manage FDA and Health Authority interactions with FDA and global health authorities, including meetings, teleconferences, and wri

About the job Associate Director, Global Patient Safety Clinical Operations Job Title: Associate Director, Global Patient Safety Clinical Operations Job Location: Boston, MA, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role At Takeda, we are a forward-looking, world-class RD organization that unlocks innovation and delivers transformative therapies to patients. By focusing RD efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an As

Applied Research Solutions is seeking an Acquisition Strategy & Documentation SME located on Hanscom AFB, in Bedford, Massachusetts. Why Work with us? Applied Research Solutions (ARS) is respected as a world-class provider of technically integrated solutions as we deliver premier talent and technology across our focused markets for unparalleled, continuous mission support. Awarded a Best Places to Work nominee since 2020, ARS recognizes that without our career- driven, loyal professionals, we would not be able to deliver state-of-the-art results for our mission partners. We firmly believe that prioritizing our employees is of the upmost importance. We provide a culture where our employees are challenged to meet their career goals and aspirations, while still obtaining a work/life balance. ARS employees are motivated through our industry competitive benefits package, our awards and recognition program, and personalized attention from ARS Senior Managers. The selected candidate will have

Our Client a well known Financial Services Company is seeking an Entry Level Analyst in their Andover, Massachusetts Location! Duties & Accountabilities: Coordinate and conduct tax document examination (IRS Forms W-8 and W-9, as well as CRS self-certification), checking for completeness and accuracy based on operational standards and regulatory requirements. Act as client relationship lead for due diligence processes as they relate to account onboarding practices, form solicitations or account remediation efforts. Serve as a primary point of contact for assigned clients and handle both day-to-day account review processes and urgent escalations in a professional and timely manner. Provide subject matter expertise where required on client & team inquiries regarding applicable statutes, tax authority guidance and general industry approaches & best practices. Address tax compliance and remediation requests with clients and/or their account holders in accordance with IRS regulations and Out

Job Family: Research and Analysis Consulting Travel Required: Up to 10% Clearance Required: None Guidehouse is a leading management consulting firm serving the public and commercial markets. We guide our clients forward towards new futures that build trust in society and your professional skills along the journey. Join us at Guidehouse. Guidehouse Insights, a part of Guidehouse's Energy, Sustainability & Infrastructure practice, is a dedicated market research and consulting team that provides in-depth technology and market analysis covering the global clean, distributed, intelligent, and mobile energy ecosystem. The team's research methodology combines supply-side industry analysis, end-user primary research and demand assessment, and deep examination of emerging technology trends to provide a comprehensive view of these industry sectors. What You Will Do: Operating in a Senior Research Analyst role, the successful candidate will serve as the main point of contact for Insights' clients