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How to be a perfect regulatory affairs manager?

What is regulatory affairs?


The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. The most significant responsibility of a regulatory professional in an export company is to get a product successfully registered and approved by the health agency of the country like FDA (Food and Drug Administration) for USA, or EMA (European Medicines Agency) for Europe.



Let us narrow regulatory affairs in branch of medical device and In vitro diagnostics (IVD).

Regulatory professionals are responsible for (topra):


  • Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products

  • Advising on legal and scientific restraints and requirements

  • Collecting, collating and evaluating scientific data

  • Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned

  • Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole

  • Help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

  • Additionally, the regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially.


The most important KPI of regulatory affairs manager are:

  • Number of registered medical device or IVD

  • Time and effort to register a product in critical market

  • Records to pass the quality management and technical documentation review


Key soft skills of regulatory affairs manager at medtech


The typical soft skills of regulatory affairs manager are:

  • Wide engineering knowledge

  • Critical thinking

  • Problem solving

  • People skills

  • Time and resource management

  • Project management

  • Conflict management


However back to KPI of perfect regulatory affairs manager, we prefer to focus on unique soft skills which you can build with us in special workshop because this is deciding your success of market access and product compliance.

1. Be in love with legal requirements


It is complex to understand rapid global compliance, from law to notification, guidance or standards. Apply the regulations to registration only or should be implemented with R&D?

The best idea is to understand regulations from different resources as newsletter, webinar, and training and be ready to find exact requirements tailored to company’s internal quality management system.

Be in love with wide knowledge of regulations in global compliance of medical device and IVD. Bundle the topics, underscore country specific requirements, and monitor effectiveness of actions derived of changing regulations.


2. Be intelligently communicative


Regulatory affairs manager should talk in different languages (if possible) with technical accent and cultural consideration. Every professionals understand the same formulation perhaps with own purpose and emphasis.

Regulatory affairs manager act oft as dispatcher in the middle of interdisciplinary groups. Be responsibly communicative. Sometimes it is way important than doing.


3.Set priority through regulatory life

The regulatory manager is always overwhelmed by emails, meeting, inspections findings and projects. The priority of the actions is the key. The most important and urgent should be solved firstly.

Have you experienced that the whole company made efforts in a market with endless hours. At the end few sales activities exist. Return to investment is also a good mind affecting regulatory departments.


4. Be a tracker

A good regulatory manager knows by when from whom which exact task upon which requirements should be completed. In the reality the tasks are multiplied.

Traceability is not a topic at verification and validation at development. Regulatory manager should trace critical tasks like for health.


5. Be a cook

Regulatory affairs manager has to cook different dishes for each fancy guest. Firstly you have to master the diversity of regulatory demand, secondly you should always has a goal (time to market). Behind you there is a team with variable skills following your order.

Be ready that every registration of medical device or IVD is a run of misplanned and unpredictable 10 course menu.


For team leader in the regulatory world of medical device


Every team leaders dream is that team colleague work on efficient country approval. However the most elements are ignored:

  • Performance in critical country (US, EU and China)

  • Share and communicate regulatory knowledge in cross-functional group

  • Optimised internal process

  • Further education of team colleagues

For junior manager beginning regulatory career

The current junior manager is future senior or leader manager. Oft the first impression at regulatory affairs is deeply anchored.

We recommend some actions below:

  • Look up how supervisor or key RA manager solve their regulatory tasks

  • Monitor and look after international legislative

  • Pre-actively exchange with experts in other departments

  • Build own tactic to achieve individual goals

Why kaizen management in regulatory affairs?


Kaizen is a concept referring to business activities that continuously improve all functions. The Japanese word kaizen means 'change for better' (from 改 kai - change, revision; and 善 zen - virtue, goodness) with the inherent meaning of either 'continuous' or 'philosophy' in Japanese dictionaries and in everyday use.

We realize that many companies are successful with kaizen in production however it is rare in regulatory affairs. We want to make regulatory science in term of continuously improvement with your regulatory elements.

Here are some examples of improvement

For the company

  • How to communicate cross different departments?

  • How to improve communication with subsidiary, consulting or distributor in other country?

For RA team

  • How to optimise RA process?

  • How to make a reproducible country folder for the team so that everyone can follow the submitted dossier in the past?

For registration

  • How to improve the efficiency of e.g. Chinese registration?

  • How to transfer home country dossier (EU MDR or US FDA) at global registration?

  • How to use lessons learned after product approval?


Either you are working for, with or at market access of medical device and IVD. We invite all kinds of stakeholder at industry of medical device for a free kick off meeting and filter the regulatory enhanced factors to work together with your team in an in-depth workshop.


Another option is to book wished E-Learning topics and get a FREE workshop for your company during the one year academy.

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