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Our client is currently seeking a meticulous and detail-oriented Device Documentation Lead to join a leading pharmaceutical company within the Devices, Artwork, and Packaging team. This role can be based at one of their campuses in Braine l’Alleud (BE), Slough (UK), Bulle (CH), or remotely within the EU. As the Device Documentation Lead, you will play a crucial role in supporting the creation of Device Documentation for a Drug-Device Combination Product currently in development.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Device Documentation Lead will be varied however the key duties and responsibilities are as follows:
1. Author or review relevant documents and generate scientific protocols and reports that support the Design History File, Technical Documentation, and Source Reports for regulatory license applications.
2. Manage documentation for the drug delivery device currently under development in collaboration with a partner.
3. Collaborate with technical, quality, regulatory, and safety experts in a team environment.
4. Contribute to the preparation of regulatory submissions with business partners by coordinating the elaboration of relevant source reports and managing the review and approval process in the appropriate electronic document management system.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Device Documentation Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a related field.
2. Extensive industry experience in Medical Device and/or Drug-Device Combination Product environments.
3. A working knowledge and practical experience with Drug Delivery Devices Regulations: EU MDR, Art 117, GSPR, 21CFR part 820, 21CFR part 4, and ISO13485 and in GMP.
Key Words: Device Documentation Lead / Drug-Device Combination Product / Medical Device / Regulatory Submissions / Design History File / Technical Documentation / Pharmaceutical / EU MDR / GMP / ISO13485 / Project Management
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Our client is currently seeking a meticulous and detail-oriented Device Documentation Lead to join a leading pharmaceutical company within the Devices, Artwork, and Packaging team. This role can be based at one of their campuses in Braine l’Alleud (BE), Slough (UK), Bulle (CH), or remotely within the EU. As the Device Documentation Lead, you will play a crucial role in supporting the creation of Device Documentation for a Drug-Device Combination Product currently in development.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Device Documentation Lead will be varied however the key duties and responsibilities are as follows:
1. Author or review relevant documents and generate scientific protocols and reports that support the Design History File, Technical Documentation, and Source Reports for regulatory license applications.
2. Manage documentation for the drug delivery device currently under development in collaboration with a partner.
3. Collaborate with technical, quality, regulatory, and safety experts in a team environment.
4. Contribute to the preparation of regulatory submissions with business partners by coordinating the elaboration of relevant source reports and managing the review and approval process in the appropriate electronic document management system.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Device Documentation Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a related field.
2. Extensive industry experience in Medical Device and/or Drug-Device Combination Product environments.
3. A working knowledge and practical experience with Drug Delivery Devices Regulations: EU MDR, Art 117, GSPR, 21CFR part 820, 21CFR part 4, and ISO13485 and in GMP.
Key Words: Device Documentation Lead / Drug-Device Combination Product / Medical Device / Regulatory Submissions / Design History File / Technical Documentation / Pharmaceutical / EU MDR / GMP / ISO13485 / Project Management
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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