Represent the Regulatory Affairs function within project teams.
Develop and implement regulatory strategies that support business goals.
Collaborate with international partners and internal teams.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Maintain knowledge of regulations applicable to submissions for medical devices.
Communicate technical and scientific information to project teams and regulatory authorities.
Collaborate with cross functional teams to develop regulatory strategy.
Cook Research Inc. manufactures medical devices and is part of the Cook Group companies. They are committed to equal employment opportunities and value diversity within their workforce.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Lead the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights for internal teams.
Hims & Hers is a health and wellness platform with a mission to improve health around the world. They are customer-centric, and focused on affordability, access, and personalized care. Hims & Hers is a public company traded on the NYSE under the ticker symbol “HIMS”.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Assist with the implementation of global regulatory roadmaps and marketing strategies.
Advise product design teams on regulatory strategy for new products.
Plan regulatory compliance for new product introductions and changes.
Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.