Medical Device Consultant - Compliance
Are you looking for a new challenge, and do you want to support our customers in developing complex products within Medical Device and Combination Products? If so, Aptio Group wants to meet you!
ABOUT THE POSITION
You will become a consultant in our business unit Medical Device and Combination Product with the potential of supporting a wide range of projects within product and manufacturing development.
As a medical device compliance consultant, you will play a key role in the medical device projects by driving QMS and Design Controls activities as well as solving issues to ensure compliance with regulations and quality processes. Preferably, you can handle compliance aspects in a network of both internal and external stakeholders, such as subcontractors and CMOs and understand the split of responsibilities. If the need arises, you are not afraid of getting your hands dirty when it comes to drafting documentation, for example for verification and validation activities, or when improving quality processes.
Projects are executed in very close collaboration with the customers, where you as a consultant will work as an integrated part of the development team. It is therefore important that you are a team player, service-minded and able to ensure alignment with the people you work with.
MAIN RESPONSIBILITIES
Responsibilities can vary from project to project but is expected to fall within the following:
- Project Management
- Contribute to the establishment of the design history file documentation and support with Design Controls and regulatory submissions
- Facilitate systematic analysis of compliance issues and create alignment with stakeholders to reach decisions and ensure progress
- Facilitate the understanding and implementation of regulatory requirements
- Implementing or updating quality management procedures and templates
- Internal and external auditing
- Ensuring quality when working with external parties such as components suppliers and CMOs
- System and process verification and validation
You will work in close collaboration with many different stakeholders for example regulatory affairs, risk managers, development engineers, project managers, manufacturing development, external vendors and CMOs and will play an important role in creating alignment between these multi-disciplinary stakeholders.
ABOUT YOU
Professional Competencies
- Sc. and/or M.Sc. in a relevant technical field.
- Experience within a similar position
- Experience with medical device development and quality management systems
- Experience with Design Controls and documentation, working with both internal and external parties such as components suppliers and CMOs
- Fluent in both written and spoken English is required
Personal Profile:
- Self-starter with personal drive
- Like being around people and enjoy interacting with team members
- Fond of new challenges and is not discouraged by uncertainties
WE OFFER
An exciting position in a company with a growth journey in which you can grow yourself – both professionally and personally, and where you will be exposed to a wide range of different work assignments. Working as a consultant, means you usually have a clearly defined task allowing you to focus on creating value and results.
For more details about the company or position, please contact André Hansen, Business Director – Medical Devices on +45 2666 7737 or e-mail Andre.Hansen@aptiogroup.com.
All applications must be submitted in English and are treated with confidentiality.
Join Our Team
ABOUT APTIO GROUP
Aptio Group is an agile and innovative Life Science Consulting Company built on a simple business model leading to efficient deliveries of our services. We employ specialized Life Science Consultants working with the largest pharma and biotech companies in Denmark and EU.
Our office is placed in Hillerød, but our consultants are primarily working at customer sites in Denmark and EU. Originally, Aptio Group was part of the leading consulting group, SIGMA in Sweden, founded in 2016, and then expanded to Denmark in late 2018. Today, we are no longer part of SIGMA but powered directly by Danir Group.
Aptio Group’s success relies solely on our relations with our colleagues and clients. If you want to be a part of shaping the future consultancy, then Aptio Group is the right place for you.