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

Your Skills & Experience

• A completed degree in a natural science discipline, such as Pharmacy, Chemistry, or Biology (university or university of applied sciences), or several years of relevant experience in sterile filling operations
• At least two years’ practical experience in a Good Manufacturing Practice (GMP) environment
• Experience in Fill & Finish operations or an aseptic manufacturing environment is an advantage. Additional experience in the chemical, biotechnology, or food industry would further strengthen your profile
• Experience in managing deviations, conducting root cause analyses, and preparing investigation reports
• Good knowledge of Quality Management Systems, as well as CAPA, Change Control, and Risk Management processes, is advantageous
• Strong analytical and conceptual skills, structured problem-solving abilities, and an independent, meticulous, and quality-focused approach to work
• Ability to grasp new concepts quickly, willingness to learn, a team-oriented mindset, initiative, and excellent communication skills
• Proficiency in Microsoft Office; experience with electronic Quality Management Systems such as TrackWise or Veeva is an advantage
• Native-level or C2 proficiency in German and a working knowledge of English are mandatory
• Work allocation: 60-80% office-based work and approximately 20% in the sterile production area (the costs of any required preliminary medical examination will be covered)

Benefits

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