Consultant - Clinical Affairs Medical Device (temporary or freelance, 40%, m/f/d)

Consultant - Clinical Affairs Medical Device (temporary or freelance, 40%, m/f/d)

Location: Greater Zurich Area, remote

We are looking for an experienced clinical affairs professional with exposure to the following 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: Experience in conducting 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, prioritize competing deadlines, and provide pragmatic, evidence-based recommendations

Your skills and experiences

• 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, 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

Your benefits

• Work in an ambitious, growing consultant company 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

Who we are

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device and IVD industries. If you enjoy working with people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.