Our client specializes in the innovation of consumer healthcare products and especially in over-the-counter products (OTC). Their mission is to bring to the world new health products that combine scientific progress with consumer insights to improve people’s lives and health. They develop these innovations for its two business units: sales to third party customers and sales from own brands in a selection of categories: head lice treatment, insect control and premium dietary supplements.
To support and reinforce their team they are looking for a Regulatory Affairs Manager.
We have an exciting opportunity for an experienced Regulatory Affairs Manager. You will become part of the Regulatory Affairs team. The team collaborates closely with all kinds of internal and external departments, including the colleagues in the US, R&D on new developments, towards authorities, …
You will be the internal expert on regulatory affairs.
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 their US brand, 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.
You will be working in the Innovation Lab team with 2 other colleagues, reporting to the Head of Regulatory.
Responsibilities & Accountabilities
The Regulatory Affairs Manager is responsible for the these
- 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 the client
- Regulatory input in R&D projects
- Vigilance Oversight
Experience, Skills and Knowledge
- 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.
Our clients core values
- Everyday dedication
We are looking for a RA Manager who will be responsible for Regulatory Affairs. You have a sound knowledge/experience of Regulatory Affairs. You ensure the regulatory affairs are well taken care off. You are business oriented and a true team member. You will be involved from start in regulatory aspects on developments (internal R&D) where you thrive in a dynamic business environment.