Company / Business Unit:
Hamilton Medical AG
Hamilton Medical is seeking a highly skilled and experienced Project Leader to be an integral part of our team and play a pivotal role in leading the FDA approval process of our technology. The Project Leader at Hamilton Medical AG will be responsible for defining the plan and organize the project, including efficient management of resources and budget throughout the cycle of the medical device's approval process starting from technical documents preparation and/or revision, including Clinical Trial Management up to securing FDA approval. You will work closely with cross-functional teams (CRO, R&D, Regulatory, Clinical Affairs and Clinical Research) to ensure our products meet global regulatory standards, enabling us to provide safe and effective solutions to healthcare providers and patients. Join our team in making a positive impact on healthcare worldwide.
Your tasks, which you can perform office-based with a possibility of up to 60% home office after a 3-month probationary period, include the following:
- Develop project plan, set goals and budget as well as identify and manage resources.
- Monitor, track and report on progress and performance, including budget.
- Partner with external stakeholders to ensure robust collaboration, Clinical Research Organizations (CROs) and Key Opinion Leaders (KOLs). The initial focus of this role will be to ensure that technical files and clinical trial submission package are compiled and ready for 510K, de Novo, IDE and PMA submissions.
- Compliance Oversight: Maintain compliance with relevant regulations, standards, and guidelines throughout the development of clinical trial documentation and conduct of the clinical trial.
- Assist in preparing response to US regulatory authorities' questions within assigned timelines.
- Describes and recommends strategies to senior management for earliest possible approvals of clinical trials applications in US in close collaborations with our Regulatory team.
- Ensures that submission packages are ready for clinical trial site ethics review board/FDA applications for investigational device trial(s).
- Ensures and contributes to the development of interim or final reports for trial site ethics boards/FDA review/submission, coordinates review processes.
- Will serve as main point of contact in case of involvement of a CRO for clinical trial management and will oversee document development for clinical trial submission, conduct and close out.
- Will be responsible for CRO selection, contract management and evaluation.
- Will be leading Project Team (P-Team):
- providing functional expertise and leading P-Team.
- defining and executing strategic implementation plans.
- interfacing with other workstreams and cross-functional stakeholders.
- Performs coordination and preparation of document packages for audits and inspections from all areas of company in close collaboration with regulatory team input to minimize potential for findings of non-compliance.
- Bachelor's degree in a relevant scientific or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or medical device development.
- Knowledge of FDA regulations (21 CFR 812, 814 and 820), ISO standards (ISO 13485: 2016, ISO 14971: 2019, ISO14155:2020), Regulation(EU) 2017/745.
- Proficiency in clinical trial management Class III or Class IIb – (EU) 2017/745 or IDE 21CFR 812.
- Minimum of eight years of Project planning, risk management, time management and other project management skills in the medical device industry.
- Ability to work collaboratively in a cross-functional team environment.
- Project management qualification (PMP), Certified associate in project management (CAPM), or equivalent experience as a project manager.
- Excellent communication skills.
- Problem-solving and leadership skills.
- Contract negotiation and conflict resolution experience Project planning, risk management, time management and other project management skills.
- Fluency in the English language; German and any other language is an advantage.
Applications will be accepted until mid-February (15.02.2024).
We look forward to receiving your documents!
Are you interested? Then please apply online by clicking on the "Apply" button. If you have any questions, please do not hesitate to contact firstname.lastname@example.org with the following details:
Reference: JR-2918-fjm/Contact: Julius Thomann
Applications by post or e-mail can unfortunately not be considered.