Our client, a pharmaceuticals company based in Dublin, now has approval for the new role of Technical Subject Matter Expert for their Drug Device Combinations product portfolio. This role is approved at Associate Director, level with associated salary and benefits package.
The successful candidate will provide technical leadership for the development and life-cycle management of Combination Products (branded & generic), across multiple product presentations spanning a global internal and external manufacturing network.
As a Device Subject Matter Expert for the global network, you will be responsible for the application of Design Control in accordance with 21 CFR 820.30 and ISO 13485 to all combination products in the company’s commercial product portfolio.
- Technical support for all device and design control expertise for the development and life-cycle management
- Driving the development and commercialization of innovative device solutions during combination product development ensuring safety and efficacy for Intended Use.
- Form strategic technical partnerships with affiliate manufacturing sites and Contract Manufacturing Organizations to influence the development of combination products across a variety of technology platforms.
- Drive the implementation of processes and procedures for the streamlined development of combination products across the global manufacturing network.
- Provide support as needed during regulatory inspections and for regulatory filings related to combination product submission and launch.
The role will work closely and collaboratively with supporting functions including Technical Operations Drug Product & Packaging, R&D, Regulatory Affairs, Medical Affairs, Program Management, Manufacturing Operations, Commercial, Quality Operations and Third-Party Entities (CMO’s/CPO’s), to compliantly achieve New Product Launch, Product Technical Transfer and Lifecycle Management objectives for the combination product portfolio.
BSc in Life Science, Pharmaceutical Science, Packaging Engineering, or Chemical Engineering field required, with 10+ years relevant experience in the pharmaceutical or MedTech industry.
Advanced degrees will contribute to required number of years’ experience.
5+ years leadership experience developing, applying design control, and achieving regulatory approval for combination products, in a cross functional matrix environment.
Excellent knowledge and understanding of FDA requirements for Devices/Combination products including 21 CFR Part 4 and 21 CFR 820.30.
Strong working knowledge of ISO 13485 and ISO 14971 requirements
Possess the ability to make technical decisions within tight time constraints.
Experience in writing and reviewing complex technical documents is required.
Effective communication and relationships management skills, with internal and external customers to achieve company goals.
Strong written and verbal communication skills.
Proficiency with MS Office Suite including MS Word, MS Excel and MS PowerPoint, is required.
Please phone Larry on +353 (0)1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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