AKRN

Scientific Consulting

Regulatory Affairs and Clinical Research

Regulatory affairs and clinical development are parts of the MedTech and biotech pipeline that come after discovery research and before the product can be used. In this way, scientists in regulatory and clinical careers are important “gatekeepers” to control the access of the new medical products on the market; the main purpose of course is to keep people safe! Clinical scientists do this by determining the indications and treatment population through clinical trials. Regulatory affairs scientists do this by liaising between companies and health authorities.

There is a wide range of jobs within this sector, all goal-oriented toward developing a product that can have a positive impact on the world. These careers are often very interesting, have good job security, provide pathways to many other career fields, and have opportunities for advancement for those with MDs or PhDs.

Regulatory affairs scientists work at the interface between the manufacturer client (business) and government regulations, shepherding medical devices and diagnostics products from inception to market. It’s a career track that can move you quickly from a newbie to a specialist and reward you with weighty responsibility for important projects.  However, a job in regulatory affairs (RA) is also one of the most difficult transitions for a postdoc or graduate student. Not only is it difficult to land an entry-level RA job, but it’s also an incredibly demanding post. The work is very detail-focused, as it involves writing and reviewing documents that are thousands of pages long. It requires an understanding of science and business, as well as government language and procedures. The pressure can be intense–but for scientists with the right mindset, it can be an excellent career.

Clinical research scientists work directly with study sponsors and hospitals and their work is directly related to patient outcomes, such as in clinical trials and investigations. Clinical investigations can be run either by manufacturing companies or in academia. PhDs have many transferrable skills that are highly relevant to clinical research, so clinical research teams are often led by PhDs. Professionals in the clinical research field feel that their jobs are highly impactful, as they are at the very forefront of where science becomes medicine that can improve patients’ lives.

AKRN Fellows Program

Become a Clinical Research – or Regulatory Affairs Scientist

  • POSITION TITLE: AKRN Fellow Scientist
  • DEPARTMENT: Clinical Affairs and Regulatory Affairs
  • CLASSIFICATION: Apprentice contract (paid)
  • PLACE OF WORK: Office-based (San Sebastian de los Reyes | Madrid)

The Fellows Program is an excellent opportunity for graduates in life sciences, medicine, and pharmacology to become a part of the fascinating medical device industry. Our fellows’ program provides rigorous and comprehensive training in all areas of clinical research, regulatory affairs, and medical device development. This is a paid apprentice position and is an excellent opportunity to learn a profession and find an entry point in a dynamic and exciting industry.

Over nine months, fellows participate in course work, interactive learning, and extensive on-the-job training. Fellows are strategically assigned to projects to maximize clinical research and device development exposure. As we feel mentorship is an essential part of the program, all fellows are assigned a mentor and receive additional support and guidance from our scientists and industry experts. 

Coursework and interactive learning consist of master classes given by our subject matter experts and opportunities to attend all in-house training on preparing technical documentation, clinical investigation planning, clinical monitoring, clinical trial biostatistics, clinical data management, good clinical practice principles, and medical device development strategies.

Project work may entail many different activities, including device development plans, protocol design, technical and regulatory documentation, project plan development, and clinical trial management. To provide the toolset needed for a career in medical device development, all fellows undergo project management training and are encouraged to take on leadership roles as their skills dictate. This unique experience allows maximized exposure to clinical research, regulatory affairs, and medical device development practices. 

This unique experience allows for maximized exposure to clinical research, regulatory affairs, and medical device development practices. At the end of the program, fellows that have successfully completed the program are encouraged to apply for a scientist position in the company.

ON-THE-JOB TRAINING

  • Support preparation of clinical protocols and case report forms
  • Support regulatory and ethics committee submissions
  • Support development of MDR and IVDR regulatory documents
  • Support preparation of site monitoring documents
  • Support preparation of essential clinical documents
  • Liaise with assigned clinical sites and collect GCP documentation

POSITION QUALIFICATIONS

  • Bachelor’s degree in life sciences or pharmacology
  • Advanced degree (Masters, Ph.D. or M.D.)
  • Familiarity with the hospital environment
  • English (advanced and full professional proficiency)
  • Spanish (working proficiency)
  • Third language such as German or French is preferred

Apply here: AKRN Fellows Program

Clinical Research Scientist

Clinical Research Scientist

  • POSITION TITLE: Clinical Research Scientist / Associate (CRA)
  • DEPARTMENT: Clinical Affairs
  • CLASSIFICATION: Full-time Employment 
  • PLACE OF WORK: Office-based

POSITION SUMMARY

Under the direction of the Clinical Affairs Manager, the CRA will implement and coordinate assigned projects; pre-market trials (CE mark) and post-market registries in Europe, related to Class III implantable products. The CRA will perform the job according to internal and external requirements, including European medical device directives and national guidelines. The job duties involve managing all aspects of submissions to Ethics Committees; clinical trial contract negotiations; case report form (CRF) design and implementation; database management (data collection, review and query); clinical on-site monitoring; maintaining close contact with study site coordinators and investigators; and participating in congresses and external meetings as required. 

KEY RESPONSIBILITIES

  • Preparation of clinical protocols (and amendments), clinical trial contracts (and amendments), and case report forms
  • Manage initiation of clinical sites including Regulatory and Ethics Committee submissions, and applicable training of site on protocol and CRF
  • Organize investigators meetings
  • Ensures adequacy of regulatory documents and compliance with EC requirements. 
  • Monitoring and reporting of site enrollment progress 
  • Maintaining site and internal documentation in accordance with established SOPs
  • Ensuring clinical trial/registry contract obligations are met in a timely manner
  • Serving as key contact for assigned clinical sites throughout the study
  • Perform other related duties as assigned on request

POSITION QUALIFICATIONS

  • Experience as Clinical Trial Assistant (minimum 2 years or equivalent)
  • Experience with Medical Devices 
  • Excellent computer proficiency (Microsoft® Office); 
  • Good communication and organizational / time management skills 
  • Self-motivation with the ability to work under pressure to meet deadlines 
  • Detail and process-oriented, positive attitude and approach, multi-tasking capability 
  • Working knowledge of EU Medical Device Directives / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures
  • Bachelor’s degree in life sciences 
  • Advanced degree (Masters or Ph.D.) preferred.
  • Familiarity with the hospital environment
  • English (advanced)
  • Spanish
  • Third language such as German or French is preferred
Regulatory Affairs Scientist

Regulatory Affairs Scientist

  • POSITION TITLE: Regulatory Affairs Scientist
  • DEPARTMENT: Regulatory Affairs
  • CLASSIFICATION: Full-time Employment 
  • PLACE OF WORK: Office-based

POSITION SUMMARY

Under the direction of the Regulatory Affairs Manager, the RA Scientist will implement and coordinate assigned regulatory projects related to technical documentation needed for CE marking nd post-market follow up Europe, related to medical devices and in-vitro diagnostic products. The RA Scientist will perform the job according to internal and external requirements, including European medical device regulations (MDR and IVDR) and national guidelines. The job duties involve managing all aspects of preparation of technical documentation, submissions to Notified Body; collaboration and negotiation with regulatory authorities; design and development of CERs and PERs; maintaining close contact with clients; and participating in internal and external meetings as required. 

KEY RESPONSIBILITIES

  • Preparation of CERs and PERs
  • Manage compilation of technical documentation
  • Organize client meetings
  • Ensures adequacy of regulatory documents and compliance with EU MDR and IVDR requirements. 
  • Monitoring and reporting of timelines and project progress 
  • Maintaining site and internal documentation in accordance with established SOPs
  • Ensuring project/contract obligations are met in a timely manner
  • Serving as key contact for assigned project throughout the study
  • Perform other related duties as assigned on request

POSITION QUALIFICATIONS

  • Experience in regulatory affairs (minimum 1 years or equivalent)
  • Experience with Medical Devices 
  • Excellent computer proficiency (Microsoft® Office); 
  • Good communication and organizational / time management skills 
  • Self-motivation with the ability to work under pressure to meet deadlines 
  • Detail and process-oriented, positive attitude and approach, multi-tasking capability 
  • Working knowledge of EU Medical Device Regulation /ISO14155 standard and device development
  • Bachelor’s degree in life sciences 
  • Advanced degree (Masters or Ph.D.) preferred.
  • English (advanced)
  • Spanish
  • Third language such as German or French is preferred
International Business Development Internship

Business Development Internship

  • POSITION TITLE: Business Development Analyst
  • DEPARTMENT: Business Development
  • CLASSIFICATION: Agreement with a university or business school
  • PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid) 

POSITION SUMMARY

The role of the Business Development (BD) internship is to support international and national business development strategies to promote the AKRN consulting services. The Business Development internship supports the operational part of the company by improving access to the company´s data and then using that data to increase company efficiency and profitability. Apart from handling established customers’ details, the Business Development internship also assists to attracts new customers to the company through various promotional and advertising methods.

KEY RESPONSIBILITIES

  • Identify, qualify and contact sales leads using market intelligence databases and provide information on products and services to generate leads.
  • Maintain company CRM databases.
  • Assist in the preparation of proposals and invoices
  • Track the success of sales leads and following up on unsuccessful proposals to determine future improvements.
  • Assist in the development and implementation of the company marketing plan.
  • Undertake marketing projects as required.
  • Undertake a range of marketing and promotional activities.
  • Collect data from internal systems and external sources, prepare it for analysis, develop and run queries against that data and create reports, dashboards, and data visualizations to make the analytical results available to corporate decision-makers.
  • Assisting company executives in the identification of market trends.
  • Enabling BI tools to support both company executives in strategic and tactical decision-making processes.
  • Building BI dashboards and performance scorecards that display visualized data on business metrics (such as number projects, billable hours per employee, annual variability in workload)

POSITION QUALIFICATIONS

REQUIREMENTS

  • An agreement with a university or business school is necessary for the internship
  • Interest in International Business Development
  • Passion for the healthcare sector.
  • International consulting role spirit
  • Experience driving projects
  • Excellent computer proficiency
  • Good communication and organizational / time management skills 
  • Self-motivation with the ability to work to meet deadlines 
  • Detail and process-oriented, positive attitude and approach, multi-tasking capability

EDUCATION

  • Bachelor’s degree
  • Advanced degree preferred.

PREFERRED ABILITY

  • English (advanced/C1)
  • Spanish (working proficiency)
  • Third language is preferred.

Apply Here

Working at AKRN

Working in Medical Device Consulting
Working in Regulatory Affairs

Regulatory Affairs

  • EMPLOYEE: Ariadna Navarro
  • DEPARTMENT: Regulatory Affairs
  • PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid) 
Working in Clinical Research

Clinical Research

  • EMPLOYEE: Ruben Ruiz
  • DEPARTMENT: Clinical Affairs
  • PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid) 
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