VP Regulatory Affairs - Massachusetts, Massachusetts, United States

We are seeking a Regulatory Affairs Specialist to support the Life Cycle Management (LCM) Regulatory Affairs team in the creation,maintenance,and review of technical documentation.This role ensures compliance with European and U.S.medical device regulations,includingsuch as EU MD ...

The Director, Regulatory Affairs - Pharmaceuticals provides leadership and technical expertise for the regulatory affairs team supporting drug product. Interacts with cross-functional leadership team to support strategy and growth of organization. · ...

The Executive Director / Vice President of Regulatory Affairs will lead global regulatory strategy for a rare disease biotechnology company. · ...

This Medical Affairs Manager position will guide and influence business plans and strategies that drive global growth of specific Omnipod initiatives. · ...

We are seeking an experienced Clinical Scientist at the Senior to Director level to play a key scientific role within the Clinical Development function supporting oncology programs in early-stage clinical development. · ...

This is a job opening for a Regional Director at MSLs. The role involves leadership & team development, field strategy & execution, and skills and experience we look for. · Recruit, coach, and manage a team of high-performing MSLs. · Develop and execute territory plans in alignme ...

This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, · and reporting all usability and risk management activities through collaboration with cross functiona ...

We are looking for a Biostatistician Manager to lead our clinical affairs team. This role will play a critical part in providing statistical support for medical device studies and collaborating with cross-functional teams. · Lead and manage the biostatistics team. · ...

The Senior Manager Medical Research plays a key role in advancing externally sponsored research initiatives. · Serve as the primary point of contact for IIS and RC activities across regions · ...

This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team performing gap assessments and planning organizing executing and reporting all usability and risk management activities through collaboration with cross-functional teams.Perform thoro ...

+Ailux is an AI-native biotech company redefining how biologics are discovered and developed. · Founded in 2021 and backed by XtalPi—a global leader in AI drug discovery (#1 by market cap)—Ailux has grown to 100+ team members across Asia and North America. · Define and execute cl ...

The Clinical Project Manager is responsible for managing and executing clinical studies from study initiation through study closeout. · Coordinate and supervise study execution and contract management for usability and user preference studies. · Review and approve protocols, stud ...

The Senior Manager, Medical Research - IIS & Research Collaborations plays a key role in advancing externally sponsored research initiatives. In this position, you will lead the operational execution and oversight of Investigator Initiated Studies (IIS) and Research Collaboration ...

The role will focus on Phase 4 clinical trials, · commercial products. · Serve as the primary point of contact for IIS · and RC activities across regions · Manage communications and relationships with investigators, · academic partners, and internal stakeholders · ...

Hands-on Risk Management Subject Matter Expert within Design Quality Assurance · Perform gap assessments of risk and usability documents per EU MDR · ...

The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, · Bachelor's degree in Life Sciences, Healthcare, · Information Management, · ...

This role leads and supports medium to large-scale projects within the Quality and Regulatory Affairs function. The position is responsible for driving projects from initiation through completion, managing timelines, resources, and stakeholders, · and ensuring delivery of expecte ...

The Senior Manager Product Marketing leads development execution strategic portfolio plans drive capital equipment consumable sales alignment Candela's annual financial objectives. · ...

The Senior Manager Product Marketing leads the development and execution of strategic portfolio plans designed to drive capital equipment and consumable sales in alignment with Candela's annual financial objectives. · Build clear compelling strategic positioning and messaging tha ...

Hiring remote Field Clinical Engineers/Specialists in the Northeast region of the USA with experience in driving patient enrollment for clinical trials. · ...