Most commonly reported Work Activities

• Getting Information Observing, receiving, and otherwise obtaining information from all relevant sources.
• Evaluating Information to Determine Compliance with Standards Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
• Making Decisions and Solving Problems Analysing information and evaluating results to choose the best solution and solve problems.
• Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
• Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
• Documenting/Recording Information Entering, recording, storing, or maintaining information in written or electronic/magnetic form.
• Communicating with Persons Outside Organisation Communicating with people outside the organisation, representing the organisation to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
• Analysing Data or Information Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• Processing Information Compiling, coding, categorising, calculating, tabulating, auditing, or verifying information or data.

Most commonly reported Work Tasks

• Provide responses to regulatory agencies regarding product information or issues.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

This occupation is typically suited for people with the following Career Interests:

Investigative

The Investigative person will usually find a particular area of science to be of interest. They are inclined toward intellectual and analytical activities and enjoy observation and theory. They may prefer thought to action, and enjoy the challenge of solving problems with sophiscticated technology. These types prefer mentally stimulating environments and often pay close attention to developments in their chosen field.

Enterprising

Enterprising people like situations that involve using resources for personal or corporate economic gain. Such people may have an opportunistic frame of mind, and are drawn to commerce, trade and making deals. Some pursue sales and marketing occupations. Many will eventually end up owning their own business, or in management roles in larger organisations. They tend to be very goal-oriented and work best when focused on a target. Some have an entrepreneurial inclination.

Administrative

Administrative people are interested in work that offers security and a sense of being part of a larger process. They may be at their most productive under supervisors who give clear guidelines and while performing routine tasks in a methodical and reliable way.

They tend to enjoy clerical and most forms of office work, where they perform essential administrative duties. They often form the backbone of large and small organisations alike. They may enjoy being in charge of office filing systems, and using computers and other office equipment to keep things running smoothly. They usually like routine work hours and prefer comfortable indoor workplaces.

Relevant degree areas include life, physical, mathematical, applied and medical sciences in areas such as:

• The life sciences
• Pharmacy
• Pharmacology
• Biochemistry
• Medicinal chemistry
• Biomedical science
• Chemical and physical sciences
• Biotechnology

Training & Development Pathways

Training can also help you progress and there are both undergraduate and postgraduate courses in business and management which can support you in your career.

FET Centre Traineeship: Business Admin, Customer service, Quality Management (Quality Assurance) available around Ireland at NFQ Levels 5-6 Search FET Courses

FET PLC Courses: Business Management, Sales, Marketing, Commerce, Compliance & Data Management, and Accounting available around Ireland at NFQ Levels 5-6 Search FET PLC Courses

Apprenticeship: Principal Engineer, Lean Sigma management Apprenticeships NFQ levels 9-10 Search Apprenticeships

Higher Education CAO Entry: Business, Commerce, Law, Economics, Maths & Statistics, Accounts & Finance available around Ireland at NFQ Levels 6-8 Search CAO courses

Postgraduate Study Options Sales, Business, Accounts, Management, Financial & regulatory compliance advice, Global Trade Compliance, Governance Compliance & Data Protection in Financial Services,Medical Technology Regulatory Affairs at NFQ level 9

Last Updated: October, 2023

Salary Range (thousands per year)* €60k - €110k

Salaries vary based on employer, location, experience, duties, and role.

Data Source(s):
Morgan McKinley / CPL / Collins McNicolas/ Sigmar/ Azon

Last Updated: August, 2024

* The lower figures typically reflect starting salaries. Higher salaries are awarded to those with greater experience and responsibility. Positions in Dublin sometimes command higher salaries.

View Salary information from Indeed.ie
Note: data not aways available

This occupation has been identified as a Job in Demand by the most recent National Skills Bulletin.

This information has been derived from the Solas National Skills Bulletin (2023).

Employment grew strongly for this occupation between 2018 and 2021, although employment remained unchanged in the most recent time period. Almost three quarters were employed in industry. Despite the static employment levels in 2022, there was a significant increase in the number of employment permits issued between 2021 and 2022 (by 1,100), with the industrial sector accounting for half of the increase. Roles for which permits were issued included quality, process, and design engineers.

This occupation had the highest number of mentions of vacancies that were difficult to fill in the Recruitment Agency Survey, especially for quality control/assurance, compliance/regulatory and process engineering roles. Employers (through Skills for Growth and/or Spotlight on Skills) have cited roles in design engineering (with specific industry knowledge), quality control and production engineers as being difficult to fill. Demand continues to be strong for this occupation despite static employment levels and issues with recruiting suitably qualified/experienced candidates for these roles are likely to persist. 

• The Health Products Regulatory Authority

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