Clinical Affairs Manager

Other         ·        Geneva, Switzerland         ·       Full time / Contract

Clinical Affairs Manager with Regulatory Support Activities

Tasks

Clinical Management (60-70%)

• Elaborates clinical strategy with Executive Management
• Responsible for writing clinical documentation, including: CIP, CEP/CER, Cover Letters, CRF, Patient consent forms, patient information sheets, IB
• Responsible for submitting clinical trial dossiers to IRB/Ethics Committees and Competent Authorities
• Responsible for communication with IRB/Ethics Committees and Competent Authorities
• With the Executive management, setting up legal agreements / sponsorship with the hospitals
• Ensures Clinical operations are compliant with GCP, ISO 14155 standard and local directives (in USA, Switzerland and Europe)
• Responsible for managing CRO activities
• Manages planning and execution of clinical investigations
• Maintains a clinical bibliography vigilance
• Manages clinical data

Regulatory Affairs (30-40%)

• Supports regulatory affairs of the company, in particular:
  • Supports with the regulatory submissions (incl. 510k, Q-Sub, CE dossier)
  • Supports with the review of V&V protocols and report
  • Supports with the risk management activities

Requirements

Education and experience:

• Master or PhD in Lifescience or Engineering
• Fluent in English (Written and spoken)
• >3 years of experience in clinical affairs for Medical Devices
• >1 year of experience in regulatory affairs for Medical Devices
• Practical experience with clinical investigation submission in EU and/or US
• Experience working with Swissmedic and/or other competent authorities in Europe
• Knowledge of ISO 13485:2016 & 2017/745 MDR
• Knowledge of FDA 21 CFR 820 & FDA 21 CFR 11

Experience with the following is an asset:

• Class III Medical Device
• Active Medical Device
• Implantable Medical Device
• Medical Device for Neurology
• French is an asset

Specific skills:

• Ability to prepare clear and concise documentation
• Good communication skills
• Proactivity and adaptation to small size company

Essential skills and abilities:

Interpersonal/Team Skills

• Establishes and maintains effective relationships with management, co-workers, subordinates and customers; consistently shows concern and respect for others; exercises tact and diplomacy; accepts constructive criticism and feedback and uses suggestions to best advantage; considers the human side of problems as well as the technical side. Works well in a team effort; shows willingness to take on new approaches and additional responsibilities; provides information and/or assistance to others; strives for a win/win outcome.

Communication skills

• Articulates ideas in a clear, concise and persuasive manner; displays appropriate assertiveness when advocating point of view; actively listens to others; encourages and listens to input before taking action; provides relevant and timely information to management, co-workers, subordinates and customers; prepares concise, easily read and understood reports and recommendations; selects most appropriate means of communication.

Decision Making

• Uses good judgment to make effective decisions within appropriate timeframes; evaluates alternatives and solutions thoughtfully, objectively and quickly before making decisions; makes tough and even unpopular decisions when necessary.

Quality/Productivity / Change Management /Process Improvement

• Organizes workgroup to increase effectiveness and quality of results; identifies, implements and supports new processes to generate improvements in company/department performance; determines and implements measures to track progress and improvements. Operates with high standards. Effectively initiates change; adapts to changes from old methods; supports company change efforts. Instils commitment to environmental and safety awareness in daily work activities.

Customer Satisfaction

• Responds to internal and external customers’ needs in a timely and courteous manner; takes initiative to properly identify and resolve customer concerns; seeks customer feedback; takes customers’ interests into account when making decisions

Benefits

We offer a dynamic environment that provides ample opportunities for growth and learning, both personally and professionally. With a small team of motivated individuals, the work environment is fast-paced and energetic, allowing for collaboration and a strong sense of community.

Job ID: 7060325

About Neurosoft Bioelectronics

• neurosoft-bio.com
• 1-10 employees
• Medical Equipment Manufacturing

At Neurosoft Bioelectronics we strive toward revolutionizing the way we interface with neural tissue, allowing the development of breakthrough therapies which would not be possible with outdated clinical technology. At our core, we are committed to the design and development of better interfaces for the brain and beyond, with the aim of significantly improving the treatment of severe neurological disorders, such as epilepsy, tinnitus and deafness.