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

As a Regulatory Affairs Business Specialist, you will play a pivotal role in enhancing systems and processes to solve problems and improve the effectiveness of our regulatory functions. You will collaborate with various teams, make revisions to Regulatory SOPs and templates, and convert regulatory knowledge into viable solutions. Your role involves working on moderately complex projects, contributing to strategies, and making informed decisions. You will support audits and inspections, mentor junior team members, and manage change activities to ensure regulatory compliance.

 

Job Responsibilities:

Implement global regulatory strategies and roadmaps, aligning them with organizational objectives and the competitive market landscape. Exercise independent judgment on significant matters, ensuring adherence to company policies and regulatory requirements. Demonstrate substantial understanding of the regulator's role in the Quality System, product lines, disease states, and customers. Resolve moderate complexity requests creatively, lead safety risk assessments, and manage incidents in Trackwise. Monitor and handle potential regulatory impacts on product safety, engage with cross-functional teams, and implement continuous improvement processes. Collaborate with central and regional Regulatory Affairs teams for establishment registration, listing, and UDI/GTIN activities. Coordinate witness testing to ensure product compliance with safety regulations, maintaining contact with certification bodies and regulatory personnel. Take ownership of regulatory planning for new product introductions and changes, maintaining compliance throughout the product lifecycle. Support the development of regulatory plans, offering guidance on risk assessment and corrective actions for regulatory requirements. Develop and facilitate regulatory submissions for new and existing products, ensuring accuracy and completeness to expedite approval processes. Create, review, and validate marketing and labeling materials, supporting projects and key regulatory initiatives. Recommend enhancements in systems and processes, collaborating with other functions and revising Regulatory SOPs and templates. Implement safety and compliance requirements for product development projects, communicating regulatory standards through memos, training sessions, and deployment strategies. Administer the compliance protocol process, overseeing safety certifications and country-specific approvals to meet international standards.

 

Profile Requirement:

Bachelor's or Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or a related field. Minimum of 2 years of experience in areas such as Regulatory Affairs, Quality Compliance, or Product Development in the Medical Devices Industry (if holding a Bachelor's degree).  Preferred: RAPS RAC certification. Skills in regulatory requirements, document auditing, data management, regulatory reporting, product registrations, product labeling, strategy implementation, stakeholder management, regulatory submission documentation, conformity assessment, regulatory intelligence, regulatory compliance, risk mitigation strategies, continuous improvement, and project management.

 

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 Affairs Business Specialist 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.