EUROPEAN CONSULTING OPPORTUNITIES Join our growing consulting network in Europe. Submit your resume and hear about exciting project opportunities.

Looking for pharmaceutical, medical device, biologic, and/or biotech consulting projects in Europe? The FDA Group is seeking European consultants experienced and knowledgeable in the areas of Quality Assurance, Regulatory Affairs, and/or Qualification & Validation to join its global talent network. We are currently fielding project-based work requests and seeking qualified independent specialists to join our consulting network who would like to hear about these opportunities.

Use the button below to tell us about yourself, upload your resume. We'll be in touch to connect further about project work.

Submit your resume and join our network »

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  • The FDA Group, LLC, Compliance Consulting, Westborough, MA
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NICE TO MEET YOU We're The FDA Group—a global leader in life science staff augmentation, recruitment, remediation, and auditing.

We help life science organizations rapidly access the industry's best consultants, contractors, and candidates. We assist in every stage of the product lifecycle, from clinical development to commercialization.

Our consulting philosophy is simple: We don’t spread ourselves thin across various industries. Instead, we focus on providing a deeper, richer bench of life science talent to the companies on the frontlines of innovation. 

We help thousands of firms, including 17 of the top 25 global pharmaceutical, biotech, and medical device companies, connect with the specialists they need, when and where they need them, through the optimal workforce model.

Looking for exciting opportunities to apply your expertise in Europe? We'd love to have you on our consulting team. Apply to join our network and hear about exciting projects arising throughout Europe.

Submit your resume and join our network »

 

We're looking for expert consultants who specialize in Quality, Regulatory Affairs, and/or Qualification and Validation.

Expand the sections below to learn more about our priority areas of specialty we're looking to grow into throughout Europe. Have a different but similar skillset? Let us know—we're always looking for a variety of competencies.

 

Quality Assurance & Compliance

We're looking for industry professionals who have extensive knowledge of FDA and/or EMA guidelines, inspection techniques, and expectations that go beyond the words of regulation.

Here are a few of the skillsets we're seeking in our European consultants:

  • Quality Management Systems (QMS)
  • Remediation
  • FDA Form 483 Inspectional Observations and Warning Letters
  • Quality Assurance (QA)
  • Qualified Person (QP) and Responsible Person (RP)
  • Manufacturing and Import License (MIA) and European Market Access
  • Pre-Approval Inspection and GxP Audits
  • Quality Investigations
  • Non-Conformance & CAPA Management
  • ISO 13485
  • MDD/MDR
  • Process Analysis & Enhancement
  • Investigation, Action Plan, & Effectiveness Check
  • Regulatory Observation/Warning Letter Responses & Remediation
  • PAI & Inspection Readiness
  • Internal Audit & Remediation Services

Regulatory Affairs

Our consultants work with clients with both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage part of or the entire registration process for new drugs, biologics, generic products, and medical devices.

  • Review of client technical dossiers and developmental plans
  • Research and interpretation of regulations
  • Determination of regulatory status
  • Pre-submission review of technical documents
  • Critical writing and review of documentation
  • Clinical trial applications and notifications (IND, IDE, CTX, etc.)
  • Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
  • Orphan Drug, Treatment Use, and ANDA Suitability petitions
  • Competent authority submissions
  • Document authoring and coordination
  • GMO applications
  • CTA project management
  • Ethics submissions
  • Dossier preparation
  • Life-cycle management of National, Mutual Recognition, Decentralised, and Centralised Procedures from preparation of initial MA applications through to full post-approval support and variations
  • Full-service Regulatory Affairs Department
  • Regulatory Strategy
    Overflow Regulatory Affairs Department
  • Training

Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:

  • Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Coordinating clinical trial application filings to regulatory agencies
  • Ensuring submissions comply with regulations
  • Managing submissions and document storage processes
  • Staying abreast of all regulations to ensure documentation compliance

Commissioning, Qualification & Validation

We work with our clients to develop scalable resource plans to support validation efforts throughout the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our resources have you covered.

  • Validation Master Plans (VMPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

Why work with The FDA Group?

The FDA Group is in business to enhance the quality of people’s lives. Whether it is our clients, employees, contractors, vendors, communities, or the patients who receive the products we touch, our purpose lies in discovering meaningful ways to apply our experience, expertise, and passion for quality in everything we do.

We've worked hard to create the kinds of tight-knit relationships with our consultants and clients that facilitate deeply fulfilling and meaningful work. We hope you'll join us as we extend this culture and mission throughout Europe.

Our 5 Core Values:

  1. Respond with urgency.
  2. Find a way to make it happen.
  3. Communicate with radical candor.
  4. Be humbly confident.
  5. Be easy to work with.

Our commitment to our consultants.

Our consulting opportunities allow you to work on exciting projects at top companies in the industry.

Independent consultants and contractors trust us to match them with exciting projects and innovative organizations.

Our 95% client success rate and 97% client satisfaction rate are testaments to our commitment to ensuring our consultants are properly placed on projects that align with their knowledge and experience.

If you’re ready for new challenges, let’s connect.

Client Variety

We work with a broad range of clients, both large and small.

Freedom

Remain in control of your professional options at all times. Consulting is a two-way street.

Project Alignment

We align roles with your talents and professional goals and preferences. Our recruiting professionals and account managers bring deep industry knowledge.

Want to hear about European consulting projects? Let's connect.

At The FDA Group, we are always looking for top talent to grow our network. If you can bring experience and new perspectives to our consulting team, we invite you to use the button below to head to our consultant application form, tell us about yourself, and get the conversation started. 

Once you're part of our consulting network, you'll hear about exclusive consulting opportunities perfect-fit to apply your experience and expertise.

Submit your resume and join our network »