Regulatory affairs managers take care of the approval of medical devices.
In this article, you will learn,
- what regulatory affairs managers are responsible for,
- which skills they should have,
- how much they earn, and,
- how to find regulatory affairs managers (with a template for job advertisements).
Update: Impact of the digital transformation on the tasks of regulatory affairs managers added!
1. Responsibilities of regulatory affairs managers
Regulatory affairs managers are responsible for ensuring that
- the company’s medical devices are approved quickly, predictably, and cost-effectively,
- the approval status is maintained in the long term,
- colleagues from other departments are burdened as little as possible with these tasks, and
- the team’s knowledge of applicable regulations is always up to date.
2. Tasks of regulatory affairs managers
To achieve these objectives, regulatory affairs managers fulfill many different tasks.
a) Current tasks
Management of approval documentation
- Defining approval strategies
- Checking approval-relevant documents (e.g., technical documentation) for conformity (not only before submission) and approving them
- Completing missing documents or supporting the own team in doing so
- Compiling submission dossiers for the respective approval authority, adapting them for the respective target markets (content, language, format), and submitting them to approval authorities
Read more about the approval of medical devices in the EU and the USA and about international approval in general.
Management of approval procedures
- Managing approval projects
- Responding to requests from authorities and notified bodies or coordinating responses from colleagues
- Informing approval authorities and notified bodies about product changes
- Monitoring the validity of certificates and product registrations
Information and advice
- Advising your own company (e.g., management, development, product management) on market access, such as developing a regulatory strategy
- Monitoring regulatory changes, informing your own company and development partners about them
- Offering further training on regulatory affairs (in-house, for development partners)
- Supporting the team in the creation of procedures and work instructions, e.g., for development
Other tasks
- Organizing yourself, e.g., maintaining the product approval database, creating approval-related standard operating procedures (“process owner”)
- Participating in professional associations and standardization committees
b) Future tasks
Initiators of the change
The tasks of regulatory affairs managers will change fundamentally over the next few years. Responsible for this are:
- Artificial Intelligence
Creating (approval) documents will be fundamentally changed by Artificial Intelligence, particularly “Generative AI” such as ChatGPT: These technologies help to create, shorten, or summarize and review texts. - Digitalization
The Johner Institute is digitalizing regulatory processes in cooperation with authorities and notified bodies. As a result, approvals will increasingly be “document-free” in the future. - Business process outsourcing
Service providers can offer many tasks faster and more cost-effectively. They automate tasks and benefit from economies of scale, allowing companies to profit from this. For example, the Johner Institute already monitors regulations and takes over the post-market surveillance for manufacturers.
Tasks that will no longer apply
This eliminates tasks completely or partially:
- Creating documents
- Reviewing documents
- Converting documents into the respective format and structure of the target market
- Manual monitoring of changes to regulations
New tasks
Regulatory affairs experts should prepare themselves for new tasks:
- Advising management on regulatory strategies, especially about new developments and prioritizing target markets
- Advancing the digitalization of their area (e.g., with the support of the Johner Institute)
- Outsourcing business processes and monitoring service providers
The following video describes the impact of digital transformation on regulatory affairs departments.
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Learn more
3. Differentiation from other roles
Smaller companies often assign the role regulatory affairs manager to the same person who also holds the quality manager and Person Responsible for Regulatory Compliance (PRRC) role under Article 15. This makes sense; however, the roles should be differentiated.
a) Differences and connections to the quality manager
The objective of the quality manager is to establish and maintain a quality management system that enables the company to achieve its objectives, particularly in relation to customer satisfaction (including patient safety). Quality managers are, therefore, responsible for ensuring that
- the top management formulates quality objectives and the quality policy,
- standard-compliant operating procedures are created and further developed,
- the company works in accordance with its standard operating procedures.
In this context, quality managers carry out internal audits (e.g., in accordance with ISO 19011) and coordinate external audits, including their preparation and follow-up.
There are similarities between quality managers and regulatory affairs managers, particularly in the following activities:
- Creating and further developing standard operating procedures that not only meet customer requirements but also regulatory requirements
- Accompanying external audits (including unannounced audits) and inspections in which authorities and notified bodies evaluate the quality management system for its effectiveness in terms of customer satisfaction and compliance with regulatory requirements
- Review and approval of documents and ensuring their conformity with the company’s own and regulatory requirements
The tasks of a “regular” regulatory affairs manager do not, therefore, include
- Performing and coordinating audits
- Creating and maintaining the QM manual
b) Differences and connections to the Person Responsible for Regulatory Compliance
The Person Responsible for Regulatory Compliance (PRRC) according to the EU MDR and IVDR must also communicate with the authorities, especially to report incidents posed by the devices and recalls. The regulatory affairs manager must be informed about this communication to be able to act with the objective of not jeopardizing the approval of the device.
The vigilance system is part of the PRRC’s area of responsibility. The regulatory affairs manager is dependent on its effectiveness.
4. Necessary competences
a) Overview of competences
To be able to fulfill the tasks and achieve the objectives mentioned above, regulatory affairs managers should meet the following requirements in terms of knowledge and competence:
Specific expertise and specific competences
- Knowing and understanding national and international regulations relevant to approval (laws, regulations, directives, standards)
- Being able to assess the conformity of documents with these regulations
- Knowing and understanding the manufacturer’s devices (medical context, physical principle, technical design)
Cross-sectional competences
- Being able to create documents in English that are as error-free as possible
- Negotiation skills and binding communication in English
- Didactic skills to convey regulatory requirements
- Strong communication and assertiveness to be able to demand compliant documents even without a disciplinary function
- Experience in project management
- Precise, structured, and pragmatic way of working
b) Training
People with the following biography often have this knowledge and these capabilities:
- Completed degree in engineering or natural sciences
- Optional further training in the field of regulatory affairs and/or
- Professional experience in regulatory affairs with a medical device manufacturer
5. Potential earnings of regulatory affairs managers
The salary range for regulatory affairs managers is broad. As salaries vary internationally, please note that the following figures only apply to Germany.
| Position | Tasks, responsibilities | Salary range (in EUR 1,000) |
| Assistance | Supports other people in the regulatory affairs team, e.g., when processing documents | 35–55 |
| RA employee | Is responsible for the approval of one or more devices | 50–75 |
| Senior RA Manager | Is responsible for several markets and/or a team and also conducts trainings | 60–95 |
| Head of RA | Responsible for the entire area with several employees and may also be responsible for quality management | 80–150 |
Salaries depend not only on the position, but also on:
- Person, demographics
- Age
- Gender (unfortunately)
- Experience (often correlates with age)
- Company
- Size (larger companies tend to pay better)
- Type of company and industry (pharma and companion diagnostics often pay better than manufacturers of non-active, low-risk medical devices)
- Location (country/state, urban versus rural, remote versus in-office)
6. Finding a regulatory affairs manager
a) Via a job advertisement
Are you faced with finding a regulatory affairs manager for your company or another company? Are you still struggling or don’t have time to formulate an attractive job advertisement? No problem:
The Johner Institute has taken on the task for you and formulated a template. You can simply download the Word Document and adapt it to your circumstances.
Download template for job advertisement for regulatory affairs manager
b) Outsource the task
The capability to master regulatory requirements is essential for medical device manufacturers. It is, therefore, advisable to fill this position internally. However, some cases justify working with an external regulatory affairs manager, at least temporarily:
- A very small company cannot or does not want to assign its own personnel to this role.
- The job holder is (unexpectedly) no longer available.
- Temporary tasks need to be managed, e.g., in the case of a new development or following a warning letter from the FDA.
- No suitable candidate can be found for the position. (Admittedly, the market is pretty empty. But some jobs don’t sound very attractive either).
c) Train/have trained
Companies must train their employees if no qualified person can be found. The Johner Institute provides support with
- seminars on all regulatory topics
- the Johner institute’s Medical Device University
Contact us if you need further support or want to outsource this role.
7. Conclusion and summary
Many people associate regulatory affairs with bureaucratic tasks. However, regulatory affairs managers are transforming themselves into strategic advisors for top management. Only an understanding of the regulations and the consequences of device approval will help them target the right markets with the right devices in the right order and bring them to market quickly.
Digital transformation and Artificial Intelligence procedures will affect regulatory affairs managers more than many other roles. This is something you should prepare for.
Change history
- 2024-03-27: Factors affecting salary added
- 2023-05-19: Article completely revised and restructured; current trends added
- 2016-09-27: First version of the article created
