- Provide end-to-end regulatory guidance for FDA SaMD submissions, including 510(k), De Novo, Pre-Sub, etc.
- Develop and review documentation:
- Work in company
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members
Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead global regulatory efforts across development programs. · Develop and execute regulatory strategies for assigned programs from early development through approval. · Prepare submi ...
Boston1 month ago
-
Monte Rosa Therapeutics seeks an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs in immunology. · ...
Boston1 month ago
-
Monte Rosa Therapeutics is seeking an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs. · ...
Boston3 weeks ago
-
Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. · ...
Boston, MA3 weeks ago
- Work in company
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members
· Overview · Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. The ideal candidate will be responsible for developing and execu ...
Boston, Massachusetts, United States2 days ago
-
This pharmaceutical company is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. · ...
Boston1 month ago
- Work in company
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members
Director, Regulatory Affairs – Global Regulatory Strategy · Location: Boston, MA USA · Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on imm ...
Boston $180,000 - $240,000 (USD)1 week ago
-
This is a great opportunity for someone who enjoys working in a hands-on start-up environment where you can genuinely influence how clinical quality is embedded across trials. · ...
Boston1 month ago
-
Hartman Young is working with an innovative biotech oncology company to support the appointment of a Pharmacovigilance (PV) Consultant. · ...
Boston1 month ago
-
We are an early-stage MedTech company developing a breakthrough technology in pediatric orthopedics. We have a working prototype, initial pre-clinical data, strong IP (patented), and in process with LOIs from key opinion leaders and potential strategic partners. · This is a true ...
Boston1 month ago
-
We are seeking a highly accomplished Senior Vice President–level Regulatory Affairs Consultant to immediately join our executive leadership function and provide high-level regulatory oversight across a rapidly expanding portfolio.This opportunity is designed for an elite regulato ...
Boston1 month ago
- Work in company
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members
Director, Regulatory Affairs – Global Regulatory Strategy · Location: Boston, MA USA · Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on imm ...
Boston, MA1 week ago
-
We are seeking a Research Administrator II to manage a complex portfolio of research grants including pre- and post-award functions. · Manage a complex portfolio of research grants. · Oversee pre- and post-award functions. · ...
Boston1 month ago
-
We are seeking a Research Administrator II to manage a complex and large portfolio of research grants including both pre and post award functions. · The organization is internationally renowned for its commitment to cutting edge research and excellent patient care uniquely positi ...
Boston1 month ago
-
We are seeking a Research Administrator II to manage complex research grants, including pre and post-award functions at our internationally renowned organization. · Manage a complex portfolio of research grants. · Oversee pre and post-award functions. · Ensure effective grants ma ...
Boston $45,000 - $70,000 (USD) per year1 week ago
-
The CMC team within Alira Health Boston LLC advises and assists biotechnology companies to manufacture therapeutic biologics for clinical testing. · This is a leadership role to help guide and manage the CMC group, · working in partnership with the Senior Vice President.Serve on ...
Boston1 month ago
-
We are hiring for one of our clients for Lab Vantage Validation Test Analyst position in Boston.We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, · ...
Boston1 month ago
-
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc ...
Boston $196,000 - $269,500 (USD)6 days ago
-
We are seeking a Research Administrator II to manage a complex and large portfolio of research grants including both pre and post-award functions. · Manage a complex and large portfolio of research grants. · Oversee pre and post-award functions. · ...
Boston, MA1 month ago
-
Senior Vice President–level Regulatory Affairs Consultant to provide high-level regulatory oversight across a rapidly expanding portfolio. · Define and approve global regulatory strategy. · Oversee preparation of INDs, NDAs, BLAs, and international submissions. · ...
Boston, MA1 month ago
-
Job Title: Research Administrator II · Job Description · We are seeking a Research Administrator II to manage a complex and large portfolio of research grants, including both pre and post-award functions. Our organization is internationally renowned for its commitment to cutting- ...
Boston, MA $45,000 - $70,000 (USD) per year1 week ago
Digital Health FDA Consultant - Boston - Saviance
Description
Job Title: Digital Health FDA Consultant
We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process.
About the Role
-
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members Boston
-
Director, Regulatory Affairs
Only for registered members Boston
-
Director, Regulatory Affairs
Only for registered members Boston
-
Director, Regulatory Affairs
Only for registered members Boston, MA
-
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members Boston, Massachusetts, United States
-
Vice President of Regulatory Affairs
Only for registered members Boston
-
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members Boston
-
Senior Manager of Clinical Quality
Only for registered members Boston
-
Pharmacovigilance (PV) Consultant
Only for registered members Boston
-
COO/CTO - CoFounder
Only for registered members Boston
-
Senior Vice President, Regulatory Affairs
Only for registered members Boston
-
Director, Regulatory Affairs – Global Regulatory Strategy
Only for registered members Boston, MA
-
Research Administrator II
Only for registered members Boston
-
Research Administrator II
Only for registered members Boston
-
Research Administrator
Only for registered members Boston
-
Director CMC Operations
Only for registered members Boston
-
Lab Vantage Validation Test Analyst
Only for registered members Boston
-
Associate Director, US Commercial Counsel
Only for registered members Boston
-
Research Administrator II
Only for registered members Boston, MA
-
Senior Vice President, Regulatory Affairs
Only for registered members Boston, MA
-
Research Administrator
Only for registered members Boston, MA