Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

Job Description

Role:

Ensure timely and accurate responses to regulatory inquiries received from global competent authorities. Collaborate with various professionals within the business unit to facilitate and develop responses to inquiries from regulators in accordance with written procedures and global requirements.

Responsibilities:

• Coordinate with business experts to determine the information required for drafting inquiry responses.
• Review complaints to ensure all necessary information for inquiry responses is present and determine if further investigation is needed.
• Write, track, and submit inquiry responses to the necessary authorities.
• Monitor and improve tracking/control systems for regulatory inquiry responses.
• Log new inquiries into tracking tools and systems.
  
  
  

Profile Requirements:

• Bachelor's degree or higher in a relevant field (biomedical engineering, science, healthcare, etc.).
• 4+ years of experience in the medical device industry or another regulated sector.
• Knowledge of applicable medical device regulations and standards.
• Strong writing skills, attention to detail, and problem-solving abilities.
• Proficiency in Microsoft Office applications. Experience with complaint handling tools is a plus.
  
  
  

What We Offer:

• Competitive salary and secondary benefits.
• Opportunity to work in a dynamic and innovative environment.
• Opportunities for professional development and growth within the company.
  
  
  

Commitment to Diversity:

We are proud to be an equal opportunity employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. Therefore, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.