Job description
We are seeking a highly experienced Senior Regulatory Affairs Lead with 7–10 years of medical device regulatory experience to oversee a small team and drive critical international registration renewals. This hybrid role, based in Minneapolis/Plymouth, Minnesota, requires a strategic yet hands-on leader who will act as the primary interface with client stakeholders while managing project timelines, deliverables, and regulatory documentation workflows. The ideal candidate is a strong communicator, organized, and ready to start immediately or within one week.
Key Responsibilities
- Serve as the single point of contact for client stakeholders, ensuring smooth communication and alignment.
- Lead, coordinate, and oversee the work of two Regulatory Affairs Specialists.
- Ensure all deliverables meet high-quality standards and are submitted within established timelines.
- Provide regular project updates, escalate risks or delays when necessary, and ensure transparency with leadership.
- Contribute hands-on to regulatory activities, including document retrieval, preparation, and submission.
- Collaborate closely with the client’s Program Manager and Director of Regulatory Affairs.
- Maintain and optimize tracking dashboards for project reporting and workflow management.
- Strategically distribute workload across the team based on country assignments, urgency, and priorities.
Requirements
Required Qualifications
- 7+ years of Regulatory Affairs experience within the medical device industry.
- Minimum 2 years in team leadership or project management roles.
- Deep understanding of international registration and renewal processes.
- Expert-level knowledge of regulatory documentation structures, including:
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- EU Technical Documentation
- Experience with document management systems (Windchill preferred).
- Strong leadership, communication, and stakeholder management skills.
- Ability to work independently and lead a team with minimal client oversight.
- Must be located in the Continental United States.
- Availability to start immediately or within one week.
Preferred Qualifications
- PMP or similar project management certification.
- RAC certification.
- Experience supporting APAC and LATAM regulatory submissions.
- Previous experience with Philips or other major medical device OEMs.
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!