- Plats: Uppsala
- Tjänst: R&D Device Design Control Lead
- Sektor: Life Science
- Anställningsform: Full-time
- Startdatum: Immediate
Our customer in Uppsala are seeking a highly motivated and experienced R&D Device Design Control Lead to join their team.
Dina främsta arbetsuppgifter:
In this role, you will play a pivotal role in ensuring regulatory compliance, driving consistency, and enhancing the efficiency of medical device development projects. This is a unique opportunity to work in a cross-functional environment and contribute to innovative healthcare solutions.
Key Responsibilities
- Implement and maintain the design and development process, ensuring compliance with regulatory requirements and industry best practices.
- Develop and update design control documentation, including Design & Development Plans, Design Input Requirements, and Traceability Matrixes such as design verification/validation reports.
- Drive continuous improvements in the design control process, striving for best-in-class efficiency and effectiveness.
- Coordinate and facilitate cross-functional team meetings related to design control throughout all stages of development projects.
- Collaborate closely with Project Managers, Project Risk Managers, and Chief Design Experts to ensure the successful execution of development projects.
- Participate in risk management activities in accordance with ISO 14971, identifying, assessing, and mitigating risks.
- Provide expertise and support during audits, inspections, or inquiries from regulatory authorities.
Det här jobbet är som gjort för dig om.
Skills & Qualifications
- Master’s or Bachelor’s degree in Life Sciences or a related discipline.
- Several years of experience in device design control within the life sciences industry.
- Fluent in English with strong written and verbal communication skills.
- Experience with GMP is required.
- Proficiency in regulatory frameworks such as EU MDR 2017/745, 21 CFR 820.30, and ISO 13485 Quality Management System is essential.
- Desired knowledge in Risk Management (ISO 14971/ISO 24971) and Usability Engineering (IEC 62366) for medical devices.
- Experience in device development and leading cross-functional teams across functions such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial is advantageous.
If you are passionate about driving innovation in medical device development and excel at working in a collaborative, regulatory-driven environment, we’d love to hear from you!
Att jobba med oss innebär.
At agap2, we specialize in the Life Sciences industry, offering exciting and challenging roles with our clients. We are proud of our talented consultant team and strive to create an inspiring and supportive work environment where each individual has the opportunity to grow and develop in their role.
We offer you:
- A positive and inclusive workplace where your commitment is valued.
- Opportunities to work with and learn from industry experts at leading companies in the Life Sciences industry.
- Professional growth through internal training and being part of a consultant team with diverse expertise.
- A dynamic and challenging role where you can develop both professionally and personally.
- A workplace that fosters strong team cohesion, with regular follow-ups with your consultant manager and team-building events like activities, dinners, and after-work gatherings.
- A comprehensive benefits package, including a collective agreement, fixed salary, extra vacation days, wellness benefits, health insurance, travel pass, and more.
How to Apply
Please submit your application with your CV and a brief cover letter explaining why you are the ideal candidate for this role.
If you have any questions about the position, feel free to contact Jessica Keränen, Senior Recruiter, at jessica.keraenen@agap2.se. Please note that applications via email will not be considered; we kindly refer to the job advertisement for applications.