Senior Regulatory Affairs Specialist
Do you want to be a Senior Regulatory Affairs Specialist? I am currently looking for a Senior RA specialist on behalf of a growing, international organisation in the medical devices industry. You will be part of the Regulatory Affairs department, together with five RA professionals. As a Regulatory Affairs Specialist you will report to the Regulatory Affairs Manager on site. This professional medical devices organisation is located in Limburg.
You will be responsible for:
- Ensuring that the assigned products are in compliance with the relevant regulations;
- The coordination, preparation and maintenance of submissions for the EMEA region and Europe;
- Defining regulatory requirements for EU and EMEA submissions;
- The coordination of recalls;
- Participating in complaint handling by analysing complaints and making recommendations;
- Assisting with audits from notified bodies and FDA facility inspections;
- The coordination of internal audits in collaboration with the audit department;
You will need to have the following skills
- At least a bachelor degree relating to the following sciences: physical, biological, material or engineering;
- At least six years of experience in the medical devices
- You have a good understanding of the international regulatory environment and the specific regulations in the EMEA region;
- Knowledge of ISO 13485, the MDD and FDA terminology;
- As English is the main language, your level of English needs to be sufficient (verbal and written);
- Good communication skills;
- You work accurately;
- Year contract with the possibility to obtain an indefinite contract after one year
- A competitive salary (+/- €65.000 euro gross based on knowledge and experience) excluding 8% holiday allowance
- Travel allowance;
- 26 holidays.
Interested in this role?
Are you the Senior Regulatory Affairs Specialist I am looking for? Please don't hesitate to contact Joey Wielkens on the phone number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com. You may also contact me if you have questions about this role.