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• Lead development and execution of global regulatory strategy.
• Act as a subject matter expert in regulatory affairs for product introduction.
• Participate in quality system and design dossier audits.

Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.

• 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.

• 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 development and implementation of regulatory and quality assurance strategies.
• Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
• Act as an internal SME (Subject Matter Expert) on regulatory requirements.

Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.

• 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.

• Lead the development, manufacturing, assembly, and commercialization of high‑concentration biologic delivery systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks.

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. It appears to be a growing company with a focus on innovation.

• 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.

• Partner in optimizing and streamlining design control requirements for medical devices.
• Lead process development and improvement projects with cross-functional teams globally.
• Conduct and develop training on design controls and related process changes.

Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly and fairly. They identify the top-fitting candidates and share this shortlist with the hiring company.

• Facilitate complaint investigations and ensure completeness of complaint files.
• Evaluate complaints and perform preliminary investigations, following up with healthcare professionals.
• Ensure complaint documentation complies with regulatory requirements and coordinate investigations with Quality and R&D.

Calyxo, Inc. is a medical device company that aims to improve kidney stone treatment. They are headquartered in Pleasanton, California, and are led by executives and investors with a proven track record.

• 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.

• Conduct high-quality, on-time CMC regulatory activities.
• 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.

• 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.

• Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
• Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM) and is broadening its vision beyond diabetes to empower people to take control of their health. Thousands of ambitious, passionate people worldwide are willing to fight like warriors to earn the trust of our customers.