Job description
We are seeking a highly skilled Regulatory Affairs Specialist with 4–6 years of experience to join our team on a fast-paced, deliverable-driven engagement. Based in a hybrid work model in Minneapolis/Plymouth, Minnesota, this role focuses on supporting urgent international product registration renewals and new submissions across APAC and Latin American markets. The ideal candidate is a proactive professional who can start immediately and manage complex regulatory documentation with precision and independence.
Key Responsibilities
- Interface with regional Market RA teams to gather and interpret country-specific regulatory requirements.
- Retrieve, review, and assemble documentation from DHF, DMR, DHR, and EU Technical Files.
- Navigate document management systems (Windchill preferred) to locate, verify, and extract required documents.
- Prepare submission packages following country-specific templates and regulatory guidelines.
- Maintain and update Excel dashboards to track deliverables, timelines, and submission progress.
- Coordinate document transfers (email/SharePoint) with regional RA teams.
- Provide daily progress and status updates to project leadership.
- Support coordination of notarizations and translation activities (no execution required).
- Ensure compliance with international regulatory standards, including CFG requirements.
Requirements
Required Qualifications
- 5+ years of Regulatory Affairs experience within the medical device industry.
- Strong knowledge of international registration and renewal processes (APAC and LATAM preferred).
- Practical experience with regulatory document structures:
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- EU Technical Documentation
- Experience using document management systems (Windchill highly preferred).
- Familiarity with Certificate to Foreign Government (CFG) requirements.
- Excellent organizational, analytical, and communication skills.
- Ability to work independently with minimal supervision.
- Must be located in the United States.
- Availability for occasional evening calls to accommodate APAC time zones.
Preferred Qualifications
- Experience working with ultrasound or imaging medical devices.
- Prior regulatory experience in Taiwan, Indonesia, India, Saudi Arabia, or Mexico.
- RAC certification.
- Experience supporting submissions in FDA warning-letter situations.
Why choose us
- An international community bringing together more than 110 different nationalities
- An environment where trust is central: 70% of our leaders started their careers at the entry level
- A strong training system with our internal Academy and more than 250 modules available
- A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, 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 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!