Consultant Clinical Development
Our team is expanding, and we need a talented clinical development consultant to join us in meeting our clients’ needs at Key2Compliance. Your skills will be an integral part of what we offer our customers. You will join a company consisting of both experts and generalists, providing our customers with regulator and quality assurance support, planning and conducting clinical investigations and clinical evaluations. Together, we can provide our clients with the most qualified support available.
Since 1994, we’ve been helping companies develop safe products for patients worldwide. Join our team of dedicated co-workers in a positive atmosphere, where there are ample opportunities for your growth and development in the industry.
About the role
As a Clinical Development Consultant, you will be part of our team of specialists that work with a wide variety of products within MedTech and IVD, as well as combination products. Apart from working with other members of the Clinical Development team, you will also collaborate with colleagues in our QA/RA, Pharma, Biological Safety, and Training & Courses teams. As a consultant, you will manage your own projects in dialogue with the client and with support from the team, writing evaluation plans and reports for regulatory submissions of products.
You will be supporting medical device manufacturers with developing clinical and performance evaluation strategies and, depending on your experience, assisting clients in designing and documenting their clinical investigations and/or clinical performance studies. The Clinical Development team works both with medical devices and in vitro diagnostic medical devices and we assist our clients in evaluations from the planning stage to the investigation/study phase, as well as in writing reports for regulatory submission and responding to and resolving Notify Body questions. If you enjoy teaching, there is a possibility to assist the Training & Courses team with giving courses in e.g. clinical and/or performance evaluations.
Typically, each consultant works with 2-3 projects simultaneously with clients within the small to medium-sized segment. The projects consist of everything from short-term to longer assignments, giving you an interesting variety in your daily work.
About you
To thrive in this role, we believe that you should possess several years of experience in the medical device/IVD industry, with a specific focus on clinical and/or performance evaluations, ideally spanning various product types. Documented experience in conducting evaluations, involvement in risk management, and post-market performance follow-up is deemed advantageous. Additionally, expertise in project management and strategic planning within clinical development is highly valued.
Your proficiency should extend to excellent writing, strong communication, and presentation skills in both Swedish and English. An analytical mindset is a key attribute. We envision you as a team player with a penchant for sharing knowledge, demonstrating your ability to work in a structured and well-organized manner. The journey ahead is filled with opportunities for your growth and success.
Key Responsibilities
You will support our clients with:
- advice in clinical/performance evaluations
- writing plans and reports
- assist in developing investigation/study documentation
- performing GAP analyses towards relevant regulations, standards and guidelines
- project management
- coordination with other teams at Key2Compliance to achieve the best possible evaluation of products
- support in communication with notified bodies
There is flexibility in the role depending on your interest and wish for continued professional learning.
Qualifications
Education Requirements/Certifications
- Ph.D. or Master’s degree in relevant field or through work acquired relevant knowledge
Required Knowledge/Skill
- In-depth knowledge of the requirements for Clinical and/or Performance Evaluation in MDR 2017/745 and/or IVDR 2017/746 including applicable guidelines
- Full professional written and oral communication skills in English
- Proficient in spoken and written Swedish
- Thorough but pragmatic
- Solution oriented
- Positive
- Flexible
Information and contact details
Place of employment: Lund, Sweden
Scope: Full time
Questions: Please contact Johanna Fugelstad, johanna.fugelstad@key2compliance.com
Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.
We look forward to receiving your application!
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