Job description
Join Our Team as a Junior Regulatory Affairs Specialist!
Are you ready to take your career to the next level in the exciting world of regulatory affairs? We are on the lookout for a passionate and driven Junior Regulatory Affairs Specialist to become a vital part of our dynamic team!
In this role, you will dive into the fascinating realm of global regulatory standards and guidelines, where your expertise will play a crucial role in shaping the future of our innovative medical devices. You will have the opportunity to manage multiple projects independently, gaining invaluable experience and contributing to our mission of delivering high-quality healthcare solutions.
Key Responsibilities:
- Ensure compliance with global regulatory standards and guidelines, including ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR.
- Prepare and submit regulatory documentation to relevant authorities.
- Collaborate with cross-functional teams to support product development and market access strategies.
- Monitor and interpret regulatory changes and assess their impact on the organization.
- Manage multiple regulatory projects simultaneously while maintaining high-quality standards.
Key Requirements:
- Minimum 2-4 years of experience in regulatory affairs, with a focus on medical devices.
- In-depth understanding of global regulatory standards and guidelines.
- Strong communication, organizational, and project management skills.
- Ability to work independently and manage multiple projects simultaneously.
- Fluency in English is required; additional language skills are a plus.
Preferred Qualifications:
- Experience with other international regulatory bodies (e.g., FDA, EMA) is a plus.
- Advanced degree in a related field (e.g., Regulatory Affairs, Biomedical Engineering, Life Sciences).
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional development and career advancement.
- A collaborative and innovative work environment.
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
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 7500 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!