Publicerad: 2024-05-08
R&D Device Design Control Lead
At Galderma we're unique and we embrace difference.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: R&D Device Design Control Lead
Location: Uppsala, Sweden (hybrid)
Job Description
We are seeking a R&D Device Design Control Lead to join our team in Uppsala. As the R&D Device Design Control Lead, you will play a crucial role in ensuring regulatory compliance, driving consistency, and enhancing the efficiency of medical device development projects. This role will offer you a unique insight working in a cross functional environment.
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, Traceability Matrixes such as design verification/validation reports.
* Drive continuous improvements in the Galderma 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.
* Participate as necessary during audits, inspections, or inquiries from regulatory authorities, providing expertise and support.
Skills & Qualifications
* Master's or Bachelor's degree in Life Sciences or related discipline.
* Several years of experience in device Design Control within the Life Science Industry.
* Fluent in English with strong written and verbal communication skills.
* Experience with GMP is required.
* Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.
* Desired knowledge in Risk Management ISO 14971/ISO 24971 and Usability IEC 62366 for Medical Devices.
* Advantageous to have experience in device development and leading cross-functional teams across various functions such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.
We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.
Next steps
We welcome your application via our company website CAREERS | Galderma. If you are currently an employee of Galderma, we welcome your application via our internal career site via Workday. Apply as soon as possible though no later than the 2nd of June 2024. The selection process is ongoing and the role may be filled prior the last application date.
* If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
* The next step is a virtual conversation with the hiring manager
* The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: R&D Device Design Control Lead
Location: Uppsala, Sweden (hybrid)
Job Description
We are seeking a R&D Device Design Control Lead to join our team in Uppsala. As the R&D Device Design Control Lead, you will play a crucial role in ensuring regulatory compliance, driving consistency, and enhancing the efficiency of medical device development projects. This role will offer you a unique insight working in a cross functional environment.
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, Traceability Matrixes such as design verification/validation reports.
* Drive continuous improvements in the Galderma 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.
* Participate as necessary during audits, inspections, or inquiries from regulatory authorities, providing expertise and support.
Skills & Qualifications
* Master's or Bachelor's degree in Life Sciences or related discipline.
* Several years of experience in device Design Control within the Life Science Industry.
* Fluent in English with strong written and verbal communication skills.
* Experience with GMP is required.
* Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.
* Desired knowledge in Risk Management ISO 14971/ISO 24971 and Usability IEC 62366 for Medical Devices.
* Advantageous to have experience in device development and leading cross-functional teams across various functions such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.
We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.
Next steps
We welcome your application via our company website CAREERS | Galderma. If you are currently an employee of Galderma, we welcome your application via our internal career site via Workday. Apply as soon as possible though no later than the 2nd of June 2024. The selection process is ongoing and the role may be filled prior the last application date.
* If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
* The next step is a virtual conversation with the hiring manager
* The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.