Clinical Development Scientist

**Job Title**: Clinical Development Scientist

**Clinical Development Scientist**
You will be responsible for designing studies and clinical developments, for either the pre-market medical softwares and devices, and post-market studies. You also will be repsonsible for the protocol development, execution and follow-up.

**Your role**:

- Assist in the development of evidence generation strategies of assigned clinical studies, working within a business unit cross-functional team
- Create the subsequent clinical evaluation plans
- Develop strong collaboration with KOLs (Key Opinion Leaders) and Investigators
- Assist in delivering assigned clinical studies, working in partnership with Clinical Operations & BSDM
- Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as CSRs and CERs
- Support clinical evidence discussions with regulators, advisory boards, association and societies
- Write clinical evaluation plans, reports, PMCF studies, and clinical investigation documents in accordance with the clinical evaluation process and applicable regulatory standards (EU MDR, MEDDEV and ISO)
- Assist in the review and creation of clinical related procedures to assess their adherence to applicable regulatory standards and corporate goals.
- Determine and support the implementation of process improvements and resolution of issues
- Member of a cross functional team assisting in the development of clinical strategy
- Provide clinical insight into product specifications
- Provide input for Design Output/ program deliverables throughout product life cycle.
- Provide input into design risk management documents and post market health hazard evaluations (HHE)
- Support product usability compliance activities by providing clinical input
- Review and assess potential non-conformance and work with stakeholders for CAPA resolution
- Provide support during certification audits and regulatory inspections
- Communicate strategy and compliance activities to internal stakeholders
- Maintain clinical compliance files and tracking databases as required
- Communicate with regulatory agencies as needed

**You're the right fit if**: (4 x bullets max)
- A medical or scientific education (preferably advanced degree: MD and/or PhD).
- A demonstrated working knowledge of GCP, ISO, FDA regulations and EU-MDR regulations.
- In-depth understanding of product development and associated design controls for medical devices.
- 3+ years of experience in a similar role in the Medical Device or Pharma industry. An advanced degree will substitute for 2 years of experience.
- Self-directed with a strong work ethic, agile, and an ability to work in a goal-oriented environment.
- Ability to collaborate effectively and influence decision making with various teams cross-functional team members as well as external partners.
- Strong writing skills to produce quality clinical documents, including final reports.
- Analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians.

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