Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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

We are a leading technology company dedicated to developing innovative solutions that improve people's lives. Our focus is on creating products that are both functional and user-friendly, with a strong emphasis on sustainability and quality.

Your Role:

Ensure timely and accurate responses to regulatory inquiries received from global Competent Authorities. Work with a variety of diverse persons within the Business Unit (Image Guided Therapy – Systems) such as Complaint Investigators, Business Experts, Clinical Experts, Market Experts, Vigilance Reporting Specialists, Engineers, Field Service & Application Engineers, and Manufacturing personnel to facilitate and develop responses to inquiries from regulators and competent authorities in accordance with written procedures and global requirements. Coordinate with Business Experts and reportable complaint investigators to determine the need for information required for the drafting of inquiry responses. Provide review of complaint to ensure all information needed for inquiry responses is present; determine if further investigation is needed and track investigation to conclusion. Write, track, and submit inquiry responses to the necessary authorities. Monitor and improve tracking/control systems for regulatory inquiry responses. Perform intake of new inquiries by logging data into tracker, complaint, Teams, and SharePoint.

Profile Requirement: 

You have a bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associate’s degree may be considered for individuals with at least 5 years hands-on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field). You have 4+ years’ experience in Medical Device and/or other regulated industry. Experience in Post Market Surveillance in Medical device domain is preferred. You have 3+ years previous experience working as a biomedical engineer/risk manager/Quality and regulatory functions OR previous experience with servicing or supporting the product or comparable products in the field OR previous experience developing responses to regulatory inquiries. You have a moderate understanding of Complaint Handling, CAPA, Corrections and Removals, as well as global medical device regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO13485, ISO14971, and ISO9001. You have a background in global post market surveillance regulations (21CFR, MDD93/42/EEC and other applicable global regulations). Your skills include great attention to detail, excellent writing skills, problem solving, ability to communicate issues in a timely manner, proficiency in Microsoft Office applications. Experience with medical devices, Trackwise Complaint Handling Tool and Salesforce are a plus. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

What We Offer:

A competitive salary and secondary benefits. The opportunity to work in a dynamic and innovative environment. Opportunities for professional development and growth within the company.

Interested? Are you the Regulatory Inquiry Expert we are looking for? Send your CV and cover letter to [email address]. We look forward to hearing from you!

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