Senior Specialist Regulatory Affairs

Andocor

Andocor is a Belgian company active in the field of cardiovascular surgery and anesthesiology. At our site in Hoogstraten, we manufacture high-quality cardiac catheters and cannulae.

Our commitment to scientific research and our endeavor to excellence and quality have propelled Andocor to successfully market and sell our innovative line of cardiac catheters and cannulae worldwide. This success is a result of applying high standards of manufacturing methods, a highly-qualified scientists and production personnel and cooperating side by side with the specialists and doctors who are the ultimate judge of Andocor as their partner for better patients' care.

Job Description

As Regulatory Affairs Specialist you will ensure that all related processes and procedures meet the requirements of applicable regulatory standards, the EU Medical device regulation 2017/745:

· Maintain regulatory affairs files (e.g., registrations, CE-certificates, quality certificates)

· Organise and track market authorizations and licenses.

· Prepare and obtain clearance for EU + ROW product submissions

· Act as auditee during external Notified Body audits and follow up on any audit findings

· Support the organization in maintaining an adequate and effective quality management system

· Stay informed about regulatory developments

· Support the implementation of regulatory activities in the company processes

· Work collaboratively with other areas to effectively investigate and solve quality issues and define CAPAs

· Prepare gap analyses and actions to ensure compliance to new or updated medical device Standards and guidelines (e.g., ISO 13485, 14971, 11607, 18193, 15223, or MDCG guidance documents)

· Support the transition to MDR and maintains compliance

· Write technical and regulatory reports such as Periodic Safety Update Reports, Post Market Surveillance Plan

Qualifications

· Degree in Pharmacy, Biological or Chemical sciences, Engineering or equivalent

· A minimum of 3 years of work experience within the medical device industry in Quality and/or Regulatory.

· Strong communication, organizational skills, ability to negotiate and take decisions

· Ability to multi-task, prioritize and meet deadlines

· Strong analytical capability and problem-solving skills.

· Fluent in both English and Dutch.

· Proficient understanding of Regulation (EU) 2017/745

· Understand requirements for product cleanliness, contamination control, bioburden testing, and/or sterilization is considered a strong plus

· Experience with similar medical devices and/or sterile devices is considered a strong plus

· Experience as an internal auditor is considered as a strong plus