Decades of shared passion for product innovation and entrepreneurship.
Oystershell – based in Ghent, Belgium – specializes in development and marketing of product innovations in dermatology, lice and insect treatments, and mineral supplements. Our mission is to develop and market the most effective, safe and convenient self-medication products to help people enjoy a healthy life.
At Oystershell, we have a talented cross-functional team with an entrepreneurial, performance-driven mindset. The employee population is very diverse, with over 10 nationalities and respect for gender equality.
Our Company’s Mission
Our mission is to develop and market the most effective, safe and convenient self-medication products to help people enjoy a healthy life.
Our company values are:
- Entrepreneurial and Creative Thinking
- Collaborative Teamwork
- Respect for People
As a Regulatory Affairs Manager you are responsible for the strategic and operational management of the regulatory aspects of medical devices, food supplements, cosmetics, general sale products and biocides. Preparation of technical files for CE marking of medical devices according to MDR 2017/745 is performed in-house. Some regulatory activities are outsourced to specialized external providers (e.g. support in US activities, EU biocide and EPA work). In that case, you are responsible for the planning, preparation and compliance of these activities. You also advise and guide the R&D project managers regarding the above aspects.
Your primary tasks
- Manage regulatory activities for medical devices, biocides, food supplements, cosmetics and general sale products.
- Contact with regulatory authorities and notified bodies
- Prepare and supervise regulatory audits
- CE certification of medical devices
- Prepare technical dossiers for medical devices
- Support our customers with the submission of our technical dossiers
- Regulatory input in QMS system of Oystershell
- Regulatory input in R&D projects
- Vigilance Oversight
Your specific responsibilities
Local Responsible for Materiovigilance (MV):
- Ensure local compliance with applicable medical device Vigilance regulations
- Support in medical device activities: documentation and follow-up of incidents (non-serious and serious), local submissions to Health Authority, if applicable
- Act as local contact point for MV audits, inspections and related processes
- Support local MV agreements with third parties
- Create and implement local Medical Device SOP(s)
- Attend MV trainings and provide training materials to local employees, when applicable
Required skills, educational and experience requirements
- Master and/or PhD in (Life) Sciences (Biomedical Sciences, Pharmaceutical Sciences, Bioengineering,…)
- More than 3 years of experience as a Regulatory Affairs Manager
- Experience with EU Medical Device Regulation (MDR) 2017/745 is required
- Other relevant regulatory matters such as EU Biocides, USA FDA 510(k), dietary supplement regulation, cosmetics, can be acquired on the job. However, knowledge/experience is a plus.
- Good analytic mind and pragmatic approach to Regulatory Affairs issues
- Academic English and good knowledge of Dutch
- Knowledge of the current Office applications
- You are proactive and anticipate possible obstacles; you look for accurate solutions when necessary
Expected professional attitude
- You are interested in product design and development.
- You have a mature, positive personality and love challenges. You are passionate and have strong organizational and analytical skills.
- You have a ‘can do’ & hands-on mentality. You think customer- and solution-oriented. You are stress resistant.
- You have a learning attitude: curious and interested.
- You like to network among Regulatory Affairs peers and officers in governmental authorities.
- You are diplomatic, a goal-getter and above all, you are a team player. Through your excellent communication skills, you ensure optimal cooperation within the company with the other departments.
- It is our expectation that you live up to our quality standards as described in the quality policy. We expect you to take the necessary actions to comply with the quality objectives.
If you are interested in joining the dynamic team of Oystershell, please send your CV and motivation letter to firstname.lastname@example.org . Response and confidentiality are guaranteed.
Please note that we only accept direct applications.