Our client is a leading international producer of personal hygiene solutions for babies, women and adults. They distribute in more than 110 countries through leading retailer private labels, as well as under their own brands. The group employs over 10,000 employees, spread around the world. The group is listed on Euronext Brussels.
Their people are their most valuable asset. To support and reinforce their team they are looking for a Group Regulatory Affairs Specialist.
We have an exciting opportunity for an experienced Regulatory Affairs Specialist. You will become part of the Sustainability and Product Stewardship team. You will be the internal expert on regulatory affairs. The expertise you bring along will be specific towards ‘medical device’.
The team is a global team and future focused. You bring the relevant insights along on the regulatory aspects and you will guarantee the regulatory compliance. Besides and together with your team you will work on projects with relevance for the nearby and distant future.
It is a challenging role with a lot of autonomy and opportunities. Key challenge is to well coordinate and organise your work and be a value to the business.
Responsibilities & Accountabilities
The Regulatory Affairs Specialist is responsible for the insights and correct implementation of the RA for the region.
You will report to the Sustainability and Product Stewardship & Regulatory Affairs Director who has global responsibilities. Being a core member of your team, you will add value through finding solutions and ensuring compliant work.
- Be the responsible on Regulatory Affairs matters, with focus on ‘Medical Device’
- Follow-up regulatory requirements linked to our products and processes and embed these requirements in the quality management system
- Give guidance to the local teams on site and in sales related to regulatory requirement (i.e. QA agreements, customer questions, awareness trainings …)
- Review local Sales and Marketing material (labels, artworks and advertising) to ensure applicable quality and regulatory requirements are met.
- Assess the regulatory impact of change controls.
- Assist R&D team on regulatory requirements during design and development process
- Coordinate activities linked to the Medical Device Regulation:
- Support in RA documentation, including Technical Documentation and clinical investigations documentation.
- Support implementation of Post Market Surveillance
- Reportable events reported within time lines to competent authorities
- Participate in regulatory audits/internal audits and inspections as appropriate
- Maintains all RA related databases (i.e. GUDID, EUDAMED,…)
- As a member of the Sustainability & Product Stewardship team you will work on several projects. You will work in a global team and you will be a well respected member.
Experience, Skills and Knowledge
- Master degree in engineering / science (or equal through experience)
- At least 5 years of relevant experience, with a focus on regulatory affairs of Medical Devices Class I / II
- Knowledge of Regulatory requirements as MDR, REACH, SUPD, FDA, etc.
- Knowledge of Quality management systems as ISO13485, MDSAP, QSR, etc.
- Able to push projects forward and take full accountability
- Able to create business partners within the organization
- Strong communication skills and fluent in English, any other language is considered as an assets
- IT skills – Sharepoint / Microsoft applications
- Team player
- Be business minded and solution driven
- Keen to work on projects and willing to use your RA knowledge in a broader setting
- English is known to a high level, all additional languages are considered a plus.
Our clients core values
- Thrive for results
We are looking for a RA specialist who will be responsible for Regulatory Affairs. You have a sound knowledge/experience of Regulatory Affairs with specific focus on Medical Device. You ensure the regulatory affairs are taken care off very well. You are business oriented and a true team member. You are willing to work on projects that both enable the future business and the companies values. The working environment is very pleasant, and our clients looks for a team member that perfectly will fit.