Overview:Looking for a hands-on Quality Engineer to support manufacturing and ensure compliance with ISO 13485 and FDA regulations. This role is highly cross-functional and focused on process validation, QMS, and production quality.Key Responsibilities: Lead/support process validation (IQ/OQ/PQ, TMV, qualifications)Manage non-conformances, CAPA, and complaint handlingSupport manufacturing line quality and in-line inspectionsMaintain and improve QMS (GMP, GDP, audits)Assist with process transfers (prototype → production)Collaborate with engineering, operations, and suppliersValidation activities  Must-Have Experience: 2–5 years in medical device quality/manufacturingStrong process validation experience (IQ/OQ/PQ)QMS knowledge (ISO 13485, FDA)Experience with CAPA, non-conformance, auditsComfortable in fast-paced, multi-project environments  Nice to Have: Catheter experienceContract Manufacturing backgroundClass II/III device experience  Perks:Bonus eligible, PTO, sick time, paid holidays, 401k match

A global healthcare company is seeking a Medical Affairs professional. With a large international workforce, the company operates across pharmaceuticals, vision care (including contact lenses), and surgical solutions related to eye health. The organization has a strong presence in multiple markets and is committed to innovation, growth, and improving patients’ quality of life. Employees benefit from development opportunities within an international and science-driven environment.Your responsibilities Driving Medical Affairs excellence with a focus on ophthalmology-related products across pharmaceutical, surgical, and vision care portfolios Supporting data generation activities (e.g., real-world evidence studies, investigator-initiated trials) and related scientific publications Managing relationships with key opinion leaders (KOLs) Supporting regional and global Medical & Scientific Affairs activities Planning and leading scientific advisory boards, expert meetings, and steering committees Providing cross-functional medical and scientific support Continuously reviewing scientific publications and assessing their relevance for local product positioning Participating in national scientific conferences and congresses Delivering medical and scientific presentations internally and externally Planning, organizing, and delivering medical training sessions Providing scientific and medical input for the evaluation and approval of promotional and educational materials Conducting literature reviews and supporting medical writing activities Your profile Advanced degree in a life science discipline (e.g., medicine, pharmacy, biology, or similar), ideally with experience in ophthalmology Knowledge of healthcare systems and relevant regulatory frameworks at local and international levels, including pharmaceutical compliance and clinical research guidelines (e.g., advertising regulations, medicines legislation, Good Clinical Practice) Proactive and solution-oriented mindset with strong analytical skills Excellent networking and communication skills Ability to present complex scientific topics clearly and effectively Strong language skills in German and English

SciPro continues our long-standing exclusive partnership with a ground-breaking, medical device company who are the creators of an award-winning AI-powered imaging biomarkers and software solution. They are passionate about becoming a leader in the precision medicine space, enabling better treatment decisions for patients. We are supporting the company on their search for a Regulatory Affairs Specialist within the UK. As a Regulatory Affairs Specialist, you will be responsible for supporting global regulatory activities, ensuring products remain compliant across both EU and US regulatory frameworks. Working closely with cross-functional teams, you will help drive regulatory strategy, support product lifecycle changes, and ensure regulatory requirements are embedded across the organisation.Key Responsibilities Support FDA submissions, ensuring regulatory documentation is prepared accurately and delivered on time.Manage product changes across EU and US markets, ensuring all updates remain compliant with applicable regulatory requirements.Oversee post-market surveillance activities, monitoring product performance and ensuring ongoing regulatory compliance. Key Requirements Experience as a Regulatory Affairs Specialist or Senior Regulatory Specialist.Strong understanding of regulatory compliance for SaMD or IVD products.Experience working within EU and/or US regulatory frameworks.