Technical Product Manager – Medical Devices
The success of Neoss and our customers is powered by our people, a culture of teamwork, innovative solutions, globally Regulatory Compliance and by continually improving the effectiveness of our Quality System as a foundation for business performance. We value safety, integrity and mutual respect, supporting our employees, communities and customers, complying with all applicable laws and regulations.
Are you committed to regulatory compliance in medical devices? Do you want to make a difference in the quality of life of dental implant patients? Then, you are welcome to join us as our new Technical Product Manager.
The key responsibilities of the role
- Key member in Design Control proving technical expertise and requirement input including performing technical documentation assessment for new and changed products
- Generate and control key Technical Documentation such as Risk Management Files, General Safety and Performance requirements and EU Declaration of Conformity, write up General Product Safety requirements (SPR) Checklist and Declaration of Conformity for new or changed products
- Conduct and coordinate Risk Management File activities for Neoss products including managing and owning the process
- Be responsible for CE regulatory release of Neoss products, in close cooperation with Clinical Research, Product Development, Marketing and Operations, and EUDAMED compliance
- Compiling, providing and presenting Technical Documentation for Notified body and regulatory audits
You have an academic degree and professional experience in product development, regulatory affairs, quality or clinical research. A background from medical devices, working with Design Control, Technical Documentation, ISO 14971 Risk Management – process control and assessment control is mandatory for this position holder. It is ideally if you already have experience of working with and implementing MDR.
What can we offer you
Neoss has a strong commitment to our customers and patients. Regulatory and Quality assurance forms a key part of the organization reflecting in all areas in which Neoss® operates. Your colleagues are all highly skilled professionals with a profound industry knowledge and we are proud to recognize our employee’s contributions to the success of the business, many of whom are celebrating over 10 years of service. It is this combination of dedication and attitude that sparks the ability to be innovative and develop products to improve the treatment of patients the world over. You will join a truly international company with high ambitions for growth and future career options.
We are looking forward to receiving your application in English, as soon as possible or at the latest on the 29th November. For more information about Neoss, the role and to apply, please contact Tom Bergqvist, Moveup Consulting AB, at (0)733 87 27 22.
CV and Cover Letter should be sent by e-mail to: firstname.lastname@example.org
We are looking forward to hearing from you!
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Neoss® was founded in 2000, with the objective of “Advancing the Science of Dental Implant Treatment”, by Fredrik Engman, Neoss Chief Technology Officer, and Professor Neil Meredith. Convinced that existing implant systems were too complex, their idea was to create a much simpler and more rationalized solution. Through persistent effort and close collaborations they created a high-quality, optimized implant system. With a limited number of components, the Neoss Implant System has unique design features and a host of excellent advantages for everyone. Leading the market with ingenuity and integrity, we strive to set new standards. In developing smart treatment solutions and working closely with each practice, Neoss makes the complex less complicated. We call that Intelligent Simplicity.
Since its foundation, Neoss continues to innovate and invest in research and product development: designing, manufacturing and globally selling products of the highest quality which offer market-leading functionality. Neoss implants are manufactured in Sweden.