- Support team members in creating CE Mark submissions and change notifications to our Notified Body (NB), including responding to regulatory inquiries.
- Aid in the completion and upkeep of Technical Documentation for CE Mark, following regulatory requirements and best practices.
- Stay informed of regulatory and standards changes, assisting in updating company policies and procedures to maintain compliance.
- Provide regulatory support to cross-functional teams by interpreting regulatory requirements into actionable plans.
- Participate in process improvement projects to increase the efficiency and effectiveness of regulatory procedures.
- Assist in addressing regulatory questions from internal stakeholders such as Customer Service, Contracts/Tenders, Sales, and Marketing, providing clear and accurate regulatory guidance.
- Support the Regulatory Affairs team by managing administrative duties related to regulatory submissions, including coordinating the signing of documents, maintaining records, and ensuring that all regulatory documents are properly archived and accessible.
- Support in implementing and maintaining the Quality Management System, such as CAPA, Management Review, and audits.
- Participate in internal/external audits and inspections, ensuring that company procedures, processes, and documentation meet the requirements of the Quality Management System, ISO 13485, and other applicable regulations.
- Offer regulatory support to other departments such as R&D, engineering, and clinical affairs as needed.
- Perform other regulatory tasks and projects as assigned.
- 1–3 years of experience in regulatory affairs and/or quality compliance within the medical device sector, focusing on adherence to EU regulations.
- A Bachelor's degree in Engineering, Medical Technology, or a closely related field, or equivalent practical experience in a similar role.
- Basic understanding of global medical device regulations, including ISO 13485, the European Medical Device Regulation (2017/745/EU).
- Familiarity with EU submissions for new products and sustaining activities.
- Strong organizational and planning skills, with a proactive approach to problem-solving.
- Effective interpersonal abilities, capable of working collaboratively within international teams and across departments.
- Attention to detail, ensuring accuracy in all regulatory-related tasks.
- Fluent in English, with a minimum of C1 level proficiency for clear and effective communication.
- General computer proficiency, including familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and Outlook.
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Regulatory Affairs Coordinator - Aubonne, Schweiz - Intuitive
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 Coordinator provides essential support to the regulatory team's efforts, focusing on the fundamental tasks necessary for regulatory compliance within the EU. This role requires a basic knowledge of regulatory compliance processes and requirements. The Regulatory Affairs Coordinator is responsible for assisting in the preparation and submission of regulatory documentation, ensuring adherence to regulatory standards, and contributing to the timely launch and change of products. This position is pivotal in supporting the team's operational needs, facilitating a smooth navigation through regulatory processes, and helping to maintain the highest standards of product compliance.
Roles and Responsibilities :
Main activities
Additional activities
Qualifications
Required Knowledge, Skills, and Experience:
Preferred Knowledge , Skills, and Experience:
Early-stage knowledge of US FDA 21 CFR and 510(k) submissions is a plus.
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.
