Oystershell specializes in the innovation of consumer healthcare products and especially in over-the-counter products (OTC). Our mission is to bring to the world new health products that combine scientific progress with consumer insights to improve people’s lives and health. Oystershell develops these innovations for its two business units: sales to third party customers (Oystershell Laboratories) and sales from own brands in a selection of categories: head lice treatment, insect control and premium dietary supplements (Oystershell Consumer Health).
As a Regulatory Affairs Manager you are responsible for the strategic and operational management of the regulatory aspects of substance based medical devices, food supplements and biocides. A lot of regulatory activities are outsourced to specialized external providers (e.g. activities for our US brand RID, all EU biocide and EPA work). You are responsible for the planning, preparation and compliance of these activities. You advise and guide the R&D project managers regarding the above aspects.
In this role, your primary tasks are:
- Manage regulatory activities for medical devices, biocides and food supplements
- 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
You will be working in the Innovation Lab team with 2 other colleagues, reporting to the Chief Scientific Officer.
Required skills, educational and experience requirements
- Master of Science in a life science discipline
- More than 3 years of experience as a Regulatory Affairs Manager
- Experience with EU Medical Device Regulation is strictly necessary. Other relevant regulatory matters such as EU Biocides, USA FDA 510(k) , dietary supplement regulation, cosmetics, can be acquired on the job.
- Good analytic mind and pragmatic approach to Regulatory Affairs issues
- Academic English, knowledge of Dutch and any other language is a plus
- Knowledge of the current Office applications. Experience with an ERP package is required.
- 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.