Reg Affairs Manager CMC Writer (Medical Devices) FSP

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Currently we have an FSP opening for Reg Affairs Manager - CMC writer with focus on Medical Devises.

Key Responsibilities

• Preparation and update of high-quality Design History Files to state of art regulatory compliance for both inhaled and injectable combination products, using varied information sources and liaising closely with other company personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
• Preparation and update of Design History Files for Combination Products in accordance with current regulatory requirements across US and EU primarily
• Assist in compiling General Safety and Performance Requirements (GSPR) checklists for devices
• Assist in regulatory strategy planning for Combination Product submissions
• Assist in risk assessment processes
• Update SOPs and/or create new SOPs to detail ways of working

Required Skills:

• Experienced in Medical Device/ Combination Product CMC based regulatory affairs.Good written and oral communication skills.
• Demonstrated ability to focus, working with attention to detail and retaining critical information.
• Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with client sites worldwide.
• Demonstrated effective time management skills.

Experience:

• Global experience, (with a specific focus on US/ EU requirements), in Combination Products.
• Working experience in generating and developing Design History Files for Combination Products.
• Lifecycle management of Medical Devices / Combination products.
• Understanding of the operation of Veeva Vault document management system

Management Role:
No people management responsibility

• Preparation and update of high-quality Design History Files to state of art regulatory compliance for both inhaled and injectable combination products, using varied information sources and liaising closely with other company personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
• Preparation and update of Design History Files for Combination Products in accordance with current regulatory requirements across US and EU primarily
• Assist in compiling General Safety and Performance Requirements (GSPR) checklists for devices
• Assist in regulatory strategy planning for Combination Product submissions
• Assist in risk assessment processes
• Update SOPs and/or create new SOPs to detail ways of workin