Regulatory Affairs Specialist

Regulatory Affairs Specialist
Remote: Hybrid 2 days in the office due to the 12 months contract.
Hours: 40hrs/week (32 hours can be discussed but also with 2 days in the office)
Location: Heerlen
Duration: 12 months (possible extension)
Rate - 35 Euros/hr - 45 Euros/hr

As a Regulatory Affairs Specialist, you operate within the Regulatory Affairs (RA) team of the Customer Quality team within the EMEA Quality Operations and Transformation department.

• As an RA specialist, you are in close contact with the Corporate FCA team, Operating Units (OU) and other stakeholders aligning on Field Action packages during preparation phase.
• After Global Package approval you follow up, make the Global FCA plan fit for use for the EMEA region and after arranging formal approval, handing over the Regional FCA plan to Country RA for execution.
• Each Field Action you will be involved in can be seen as a small project, each having its own unique requirements and challenges.
• You will define the best approach for each individual action together with the concerning stakeholders.
• Being aware of the environment you identify and solve issues as they arise and can manage daily activities independently involving others when needed.
• You will be in contact with different country and regulatory representatives.

• Review Global packages provided by the OU, aligning with relevant stakeholders on the best Global/Regional approach, assuring the agreed direction is correctly captured in the final FCA plan.
• Coordinate, monitor and provide guidance & consultation for FCA planning, initiation, execution, and closure.
• Coordinate and assist in receiving feedback from Competent Authorities and/or Notified Bodies when needed.
• Adhere and comply to regulatory requirements for the EMEA region
• Participate in audits (internal, Notified Body, Competent Authority) and other governmental inspections.
• Support the design, implementation, maintenance and improvement of department systems, procedures, and processes.
• Participate in or host regulatory related meetings.

• University degree and 2-4 years relevant work experience.
• Understanding of impact of your work on RA Compliance.
• Preferred: demonstrated knowledge of regulatory Medical Device requirements related to Field Corrective Action environment.
• Preferred: knowledge / experience about Medtronic products (technical and their application) & knowledge of the Medical Device Regulation.
• Displays a Quality Begins with Me strategy to problem solving and ensures preventative and lasting resolutions to daily issues as they arise to avoid compliance risks.
• Self-motivated, self-directing, strong attention to detail and excellent time management skills.
• Strong interpersonal skills and the ability to communicate well – verbally and in writing-
• Displays initiative and is accountable for actions taken.
• Tool knowledge / affinity to work with systems (Excel, PowerPoint, Teams, SAP, FAMOUS).
• Flexible to work in a hybrid environment.

• University / master’s degree, EMEA region is scope also including Russia, will be in direct contact with Enterprise Organisation.
• Able to dig into topics BU operating Units, understanding of business details due to define at the end how to approach authorities (will be trained in buddy system on this).
• Identifying safety issues, example callback of products.