Job Description

Job description

Job Summary



The DHF Specialist is responsible for managing and maintaining Design History Files (DHFs) in compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements. With strong expertise in design controls, this role ensures complete, accurate, and audit-ready documentation throughout the medical device product lifecycle. The ideal candidate has solid experience in regulated medical device environments and collaborates effectively across cross-functional teams.



Key Responsibilities

Lead the development, compilation, and maintenance of DHFs for Class II medical devices.

Ensure full compliance of design control documentation, including Design Inputs, Outputs, Reviews, Verification & Validation, and Design Transfer.

Establish and maintain traceability across User Needs, Risk Management (ISO 14971), and Verification protocols.

Partner with R&D, Regulatory Affairs, Quality, and Manufacturing teams to ensure timely and compliant documentation.

Conduct regular DHF audits and gap assessments; drive corrective actions as needed.

Support regulatory submissions (e.g., 510(k), CE Marking) by preparing and reviewing DHF content.

Manage document control activities within QMS platforms (e.g., MasterControl, Greenlight Guru, Veeva Vault).

Contribute to process improvements in design control workflows and QMS procedures.

Provide training and guidance to engineering teams on DHF best practices and regulatory expectations.

Qualifications

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or related field.

4-6 years of experience in the medical device industry, with direct involvement in design controls and DHF management.

In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.

Proven experience with Class II devices (Class III a plus).

Proficiency in electronic QMS systems and document control practices.

Strong organizational, communication, and problem-solving skills.

Ability to work independently and manage multiple priorities in a fast-paced environment.

Preferred:

Experience supporting FDA or Notified Body audits.

Familiarity with usability engineering (IEC 62366) and software validation (IEC 62304).

Green Belt or training in Lean, Six Sigma, or CAPA systems.

Key Competencies

Regulatory Compliance

Technical Documentation

Cross-functional Collaboration

Attention to Detail

Project Coordination



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 reason, 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 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!