- 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 and 510(k) submissions is advantageous.
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Regulatory Affairs Specialist - Aubonne, Schweiz - Intuitive Surgical
Beschreibung
Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position:
The Regulatory Affairs Specialist plays an important role within the Regulatory Affairs Department, focusing on New Product Development (NPD) and sustaining activities for designated Business Units. This position requires a good foundation in regulatory compliance frameworks within the EU and the ability to support regulatory strategies in alignment with company goals. The Regulatory Affairs Specialist supports the preparation and submission of regulatory documents, ensuring products comply with rigorous standards and contribute to successful product introductions and changes.
Roles and Responsibilities:
Main activities
Additional activities
Qualifications
Required Knowledge, Skills, and Experience:
Preferred Knowledge, Skills, and Experience:
Additional Information
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift: Day
Travel: None
