Reporting into our Head of Clinical, Dr. Sarah Bosshard

Your Responsibilities

• Clinical evaluation and medical writing: Independently prepare, review, and maintain clinical documentation, particularly Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post-Market Clinical Follow-up (PMCF) Plans and Evaluation Reports
• Literature research and evidence appraisal: Conduct systematic literature searches, assess the relevance and quality of scientific publications, critically appraise clinical data, and prepare literature search reports and evidence summaries
• Post-market clinical evidence: Analyse clinical investigation results, registries, real-world data, complaints, and other post-market information, and integrate relevant findings into clinical evaluation and post-market documentation
• Scientific and clinical writing: Prepare or review clinical study protocols, clinical study reports, scientific manuscripts, abstracts, and other clinical or scientific documents, as required by project needs
• Regulatory documentation: Support the clinical sections of technical documentation, including contributions to Post-Market Surveillance (PMS) Plans and Reports, Periodic Safety Update Reports (PSURs), risk management documentation, and Summary of Safety and Clinical Performance (SSCP), where applicable
• Project and client management: Independently manage assigned deliverables, coordinate relevant stakeholders, prioritise competing deadlines, and provide pragmatic, evidence-based recommendations

Your Skills & Experience

• A Master’s degree or equivalent qualification in life sciences, biomedical engineering, dentistry, medicine, or another relevant scientific or clinical discipline. A PhD is an advantage
• At least 5 years’ experience in the medical device industry working in clinical affairs, clinical operations, or medical writing
• Experience in both dental and/or orthopaedic industries is an advantage
• Advanced technical writing skills with demonstrated experience in writing scientific manuscripts, clinical evaluation documents such as CER and CEP, and PMCF documentation
• Experience in setting up literature searches, appraise data and draft literature reports
• Experience with clinical study protocols and reports in accordance with ISO 14155 and applicable Good Clinical Practice (GCP) principles
• Experience with PMS, PSURs, SSCPs, clinical investigation planning, and post-market evidence generation is a plus
• Excellent knowledge of MDR 2017/745 Annex XIV and relevant MDCGs, preferably also FDA regulation
• Strong project management skills, with a proven track record of successfully managing multiple projects simultaneously with minimal supervision
• Ability to communicate effectively and work with teams
• Systematic and analytical thinking, process-oriented and risk-based
• Ability to gain the trust of various stakeholders
• Fluency in English is a must; proficiency in German is an advantage

Benefits

• Work at an ambitious, growing consultancy in the medical device industry
• Benefit from flexible working hours in an exciting and versatile field of activity
• Expect a pleasant working atmosphere, with uncomplicated and collegial cooperation, at a company with a flat hierachy and short decision-making processes
• Take advantage of modern and attractive working conditions and development opportunities
• Receive an attractive salary and excellent social benefits

To apply for this role, see our LinkedIn jobs page.

Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead the technical development of combination products and medical devices from concept through commercialization
• Define and assess primary packaging solutions, applying expertise in Type I glass, COP/COC polymers, elastomers, coatings, and extractables & leachables (E&L)
• Develop container closure and device integration solutions that ensure container integrity, manufacturability, and reliable product performance
• Provide technical oversight and guidance to external development partners
• Lead complex root cause investigations and resolve device and packaging-related challenges using structured problem-solving methodologies
• Author design control, risk management, verification, and regulatory documentation
• Support regulatory submissions and health authority interactions
• Ensure compliance with applicable regulations and standards, including ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 4, ISO 11040, ISO 11608, USP 1207, USP 381, and USP 660

Your Skills & Experience

• Bachelor’s or Master’s degree in Engineering or a related technical discipline
• 5+ years’ experience in medical device, combination product, or drug delivery device development within a highly regulated environment (cGxP/QSR)
• Strong expertise in container closure systems, particularly prefilled syringes and cartridges for parenteral drug delivery
• Experience with fill-finish processes, including stoppering technologies
• Solid understanding of materials science, elastomers, coatings, defect mechanisms, and performance testing
• Proven technical leadership and strong problem-solving capabilities in cross-functional projects
• Deep knowledge of the regulatory framework and industry standards governing combination products and medical devices
• Experience supporting regulatory submissions, including technical authoring for IND/IMPD and NDA/BLA filings
• Proficiency in risk management, reliability engineering, tolerance analysis, statistical methods, and process capability assessments
• Excellent communication, documentation, and stakeholder management skills
• Fluency in English is a must, German is an advantage

Benefits

• Work in the Basel area for an international pharmaceutical company in the combination product sector
• Benefit from flexible working hours in an exciting and versatile field of activity
• Expect a pleasant working atmosphere, with uncomplicated and collegial cooperation, at a company with a flat hierachy and short decision-making processes
• Take advantage of modern and attractive working conditions and development opportunities
• Receive an attractive salary and excellent social benefits

To apply for this role, see our LinkedIn jobs page.