Auf einen Blick
- Aufgaben: Lead quality and regulatory affairs in medical robotics, ensuring compliance and driving certification processes.
- Arbeitgeber: Join TWIICE, a pioneer in wearable robotics dedicated to making life accessible for everyone.
- Mitarbeitervorteile: Enjoy flexible working conditions and participate in our employee stock option plan.
- Warum dieser Job: Make a real impact on people's lives while growing with a dynamic and ethical tech company.
- Gewünschte Qualifikationen: 3+ years in medical devices, ideally with robotics; excellent English skills required.
- Andere Informationen: This role starts at 50% commitment but will grow over time as you advance with us.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
Bild zum Verschieben ziehen
Quality Affairs Manager
|| Who we are
At TWIICE, we believe that life should be accessible to all. This is why we develop exoskeletons that give people the freedom to do what they love.As a leader in wearable robotics, we keep pushing the boundaries of technology for the benefit of human beings. Fundamentally user-centered, we work everyday towards ever more inclusion through ethical technology.
|| Position
You will be responsible for ensuring our compliance with regulatory requirements in the field of medical robotics. You will also oversee the Quality system deployment, maintenance, and compliance throughout the company, as required by the regulatory requirements of the countries operated.The ideal candidate will have at least 3 years of experience in the medical device field, with knowledge of the CE-marking or FDA approval processes.Responsibilities and DutiesTake overall responsibility for Quality and Regulatory Affairs within the companyDrive certification processes and documentation complianceAssist with Quality Management System deployment, maintenance, and compliance throughout the companyDrive compliance of operations and auditability as per internal and/or external requirements.Drive internal training on regulatory requirements, quality processes and applicable standardsThis position is 50% initially but will increase in the next 12 months, and we are looking for a candidate who can commit to growing with the company. We offer flexible working conditions and participation in the employee stock option plan.
|| About you
You have a proven ability to collaborate across various groups, build relationships and manage effectively in a dynamic organization.Your work ethic is impeccable. You take pride in doing a job well.You are able to set priorities and focus on what is most important.You aspire to make the world a better place, contribute to a more equal and sustainable society. Key qualificationsProven experience in medical device environment, ideally with robotics and/or wearable robotics with the ability to act as „Responsible Person“ for the companyAt least 3 years of experience in Quality and Regulatory AffairsExcellent English verbal and written communication skillsPreferred qualificationsExperience with CE marking or FDA approval processesAbility to converse in French or willing to learnExperience in the field of wearable roboticsMaster’s degree or PhD in engineering
|| What we offer
An opportunity to make the world a better place and to have a major impact on people’s life.Growth potential. We highly value team members who have an outsized impact and provide rapid advancement opportunities. Flexible working time and conditions: our employees make their workplace one they love. Participation in the employee stock option plan.Office locationALTContactTWIICE SA, Rue de Lausanne 64, 1020 RenensE-mail: : +41 21 539 1234Website: provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to ethnicity, religion, gender, national origin, age, disability or marital status.#J-18808-Ljbffr
Quality Affairs Manager Arbeitgeber: TWIICE SA
Kontaktperson:
TWIICE SA HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Quality Affairs Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for medical devices in the countries TWIICE operates. Understanding the CE-marking and FDA approval processes will give you a significant advantage during the interview.
✨Tip Number 2
Highlight your experience in quality management systems and any previous roles where you ensured compliance with regulatory standards. Be ready to discuss specific examples of how you've driven certification processes in the past.
✨Tip Number 3
Showcase your ability to collaborate across various teams. Prepare to share instances where you've successfully built relationships and managed projects in a dynamic environment, as this is crucial for the role.
✨Tip Number 4
Express your passion for making a positive impact through technology. TWIICE values candidates who aspire to contribute to a more equal and sustainable society, so be sure to convey your alignment with their mission.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Quality Affairs Manager
Tipps für deine Bewerbung 🫡
Understand the Company: Familiarize yourself with TWIICE and their mission to make life accessible through wearable robotics. Highlight your alignment with their values in your application.
Tailor Your CV: Ensure your CV emphasizes your experience in Quality and Regulatory Affairs, particularly in the medical device field. Mention any relevant certifications or processes you are familiar with, such as CE marking or FDA approval.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving lives through technology. Discuss your experience in quality management systems and your ability to collaborate across teams.
Highlight Relevant Skills: In your application, emphasize your communication skills and your ability to manage compliance in dynamic environments. If you have experience in training others on regulatory requirements, be sure to mention it.
Wie du dich auf ein Vorstellungsgespräch bei TWIICE SA vorbereitest
✨Understand Regulatory Requirements
Make sure you have a solid grasp of the regulatory requirements in the medical device field, especially regarding CE-marking and FDA approval processes. Be prepared to discuss how your experience aligns with these regulations.
✨Showcase Your Collaboration Skills
Highlight your ability to work across various groups and build relationships. TWIICE values collaboration, so share examples of how you've successfully managed projects in dynamic environments.
✨Demonstrate Your Commitment to Quality
Prepare to discuss your experience with Quality Management Systems and how you've driven compliance in previous roles. Emphasize your work ethic and pride in delivering high-quality results.
✨Express Your Passion for Impact
TWIICE is looking for candidates who aspire to make the world a better place. Share your motivations for working in the medical robotics field and how you envision contributing to a more equal and sustainable society.