Regulatory CMC Manager, Devices
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Ware • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Develop and implement regulatory device strategies to support product development, registration, and lifecycle management.
- Collaborate with cross-functional teams, including technical, regulatory, manufacturing, clinical and quality, to ensure device-related deliverables meet global standards.
- Provide interpretation and advice on regulatory guidance on device design, development, and compliance.
- Identify and manage device-related regulatory risks and develop mitigation strategies and communication to ensure project submission success.
- Support major inspections and audits related to device development and manufacturing from a regulatory strategy perspective.
- Proactively look to continuously improve processes and systems to enhance efficiency and quality in device-related regulatory activities.
Requirements
- Bachelor’s degree (or equivalent) in engineering, life sciences, or a related field.
- Detailed experience in medical device and combination product development, manufacturing, or regulatory affairs.
- Good knowledge of global medical device regulations and standards.
- Strong project management and organizational skills.
- Ability to collaborate effectively in cross-functional teams.
- Excellent communication and problem-solving skills.
- Advanced degree (Master’s or PhD or equivalent) in engineering, life sciences, or a related field (preferred).
- Development experience ideally including previous roles within drug-device combination or vaccine products (preferred).
- Competent with risk management processes for medical devices (preferred).
- Experience working with external partners or suppliers (preferred).
- Proven ability to lead and mentor teams (preferred).
- Knowledge of emerging trends and technologies in medical devices and combination products (preferred).
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory device strategiesmedical device developmentcombination product developmentregulatory affairsrisk management processesdevice design complianceproject submissionprocess improvementquality managementglobal medical device regulations
Soft skills
project managementorganizational skillscollaborationcommunicationproblem-solvingleadershipmentoringcross-functional teamworkadaptabilitystrategic thinking