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Regulatory and Clinical Affairs Manager or Specialist
Regulatory activities in product development:35% *Participate to Regulatory strategy for new products *Represent Regulatory function on product development teams *Conduct Risk Management processes *Interaction with technical team to identify Verification / Validation Tests to mitigate risks Regulatory Affairs: 30% *Participate to the Clinical Evaluation report for product CE registration *Preparation of Design Dossier for CE-mark approval *Support submission and follow-up with the Notified Bodies *Participate to the PMA submission process at FDA Preparation of clinical study: Design / Submission:35% * Responsible for preparation of clinical study, including: *Design of study, including clinical endpoints *The writing of CIP, IB, and documents for CRF *Liaison with the investigators and hospital stakeholders to ensure the clinical study methodology and endpoints are achievable *Manage the planning of timelines and resources, internal and external, for the study (ies). *Manage EC and CA approval process.
Medical Devices - Class III
Regulatory and Clinical Affairs
Education and Experience: *Master's Degree ; preferred in Biomedical Engineering or related Engineering domains. *Minimum 5 years of experience in medical device industry, and minimum 2 years of experience in a Regulatory position, including International medical device regulatory submissions/approvals. *Experience with Class III / Active implantable devices. *Good knowledge of EU directives MDD 93/42/EEC & AIMD 90/385/EEC is a requirement. *Knowledge of US FDA regulations, 21 CFR 820, FDA Clinical Regulations is a plus *Fluent Written and Spoken English. *Knowledge of German is a plus Specific Skills: *Strong ethical standards *Knowledge of applicable laws which regulate medical device manufacturers *Strong interpersonal skills with regulatory authorities, medical stakeholders and partners *Negotiations with development teams *Project management with demonstrated ability to drive positive results *Strong technical writing skills *Demonstrated training skills *Willingness to travel Essential Skills and abilities: 1.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. 2.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. 3.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. 4.Quality/Productivity/Change Mgmt/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 previous methods; supports company change efforts. Instils commitment to environmental and safety awareness in daily work activities. 5.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.
Our client is a fast growing start-up active in the neurostimulation.
Great opportunity to develop autonomy and entrepreneurial skills within a very dynamic environment working with passionate people.