Senior Clinical Affairs- IVD & Medical Devices

We are seeking a

Senior Clinical Affairs Expert

to join a pioneering diagnostics company based in

Barcelona

.

This is a pivotal role acting as the primary strategic and operational bridge between the company and a leading global CRO, overseeing an ambitious multi-center clinical study across

Europe and the USA

.

You will be the lead interface for daily operations, ensuring the seamless execution of a large-scale clinical performance study for a novel, breakthrough device. External Partner Management:

Act as the primary point of contact for the selected CRO, overseeing site selection, qualification, and training across all sites. Cross-Functional Leadership:

Coordinate internal stakeholders across R&D, Marketing, Regulatory, and Quality departments to align clinical strategy. Global Compliance:

Ensure study phases strictly adhere to

EU IVDR

requirements and

U.S. FDA

regulatory standards. Strategic Oversight:

Monitor study progress, identify risks, and implement mitigation actions for a high-volume clinical project. Future Planning:

Contribute to the design and planning of post-market clinical follow-up studies.

Education & Training: Bachelor’s degree in Life Sciences

(Biology, Biotechnology, Pharmacy, Medicine, or similar). An

Advanced degree

(MSc, PhD, or equivalent) is highly preferred. Specific training in

Clinical Trial Management

or

Regulatory Affairs

is a strong asset.

Experience & Skills: Ideally

5–8 years

in Clinical Project Management. High-potential candidates with

5–6 years

of solid experience are also encouraged to apply. Mandatory experience in

Medical Devices

, with a strong preference for

IVD (In Vitro Diagnostics)

. Familiarity with molecular diagnostics, PCR-based assays, or nucleic acid technologies is a plus. Fluent English

is essential for daily international coordination. High level of autonomy and excellent stakeholder management skills.