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.
Managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
Ensuring that new products and documentation are compliant with applicable quality and regulatory requirements.
Serving as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, and post-clearance activities.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.
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.
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.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
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.
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.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
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.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
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.