Regulatory Affairs Specialist
Intuitive Surgical
- Aubonne, Vaud
- CDI
- Temps-plein
- Support Regulatory Team efforts in NPD projects and sustaining operations within specified Business Units, providing regulatory compliance and strategic support.
- Contribute to the preparation and coordination of EU submissions for Medical Devices, facilitating timely regulatory approvals for new products, new indications, and product changes.
- Help in creating CE Mark submissions and change notifications, including assessing the regulatory impact for product changes, and drafting responses to regulatory inquiries.
- Support the preparation of CE Mark documentation for EU submissions related to NPD projects and product changes, ensuring accuracy and completeness before RA Management review and Notified Body submission.
- Assist in maintaining Technical Documentation for CE Mark compliance, following regulatory standards and best practices.
- Participate in interactions with Notified Bodies and Competent Authorities, supporting the representation of the company's regulatory strategies.
- Coordinate registration strategy with Sales and Marketing stakeholders, aligning product launches with market needs.
- Prepare and submit Medical Device registration dossiers for assigned geographies, maintaining accurate and up-to-date clearances and records.
- Respond to regulatory inquiries from key stakeholders, including Customer Service, Contract, Tender, and Sales departments, providing timely and accurate information.
- Monitor regulatory and standards changes, aiding in the update of company policies and procedures to ensure compliance.
- Engage in process improvement projects to increase regulatory procedures' efficiency and effectiveness.
- Contribute to the Regulatory Affairs department's growth and continuous improvement through skills development and process enhancement.
- Support the implementation and maintenance of the Quality Management System, including CAPA, Management Review, and audits.
- Take part in internal/external audits and inspections, ensuring that company procedures, processes, and documentation meet Quality Management System, ISO 13485, and other applicable regulations' requirements.
- Provides regulatory support to other departments such as R&D, engineering and clinical affairs as needed.
- Execute other regulatory tasks and projects as assigned.
- 3-5 years of experience in regulatory affairs within the medical device sector, with a focus on EU regulations.
- A Bachelor's degree in Engineering, Medical Technology, or a related field is preferred, though practical experience in a similar role may also be considered.
- Good understanding of global medical device regulations, including ISO 13485, the European Medical Device Directive (93/42/EEC), and the Medical Device Regulation (2017/745/EU).
- Ability to support the management of EU submissions for NPD projects and sustaining activities.
- Knowledge of EU regulations and directives relevant to product compliance, such as RED, ROHS, and the Waste Framework Directive.
- Strong organizational and planning skills, with a proactive problem-solving approach, urgency, and commitment to results.
- Excellent interpersonal skills, able to collaborate effectively within international teams and across departments.
- Meticulous attention to detail, ensuring accuracy and completeness in all work-related tasks.
- Proficient in English, with a minimum of C1 level proficiency in both written and spoken forms.
- General computer proficiency, including Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook.
- Familiarity with US FDA 21 CFR 820.30 and 510(k) submissions is advantageous.