Most commonly reported Work Activities

•   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.
•   Getting Information Observing, receiving, and otherwise obtaining information from all relevant sources.
•   Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
•   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.
•   Interacting With Computers Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
•   Making Decisions and Solving Problems Analysing information and evaluating results to choose the best solution and solve problems.
•   Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
•   Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
•   Establishing and Maintaining Interpersonal Relationships Developing constructive and cooperative working relationships with others, and maintaining them over time.
•   Analysing Data or Information Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Most commonly reported Work Tasks

• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Coordinate recall or market withdrawal activities as necessary.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

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

 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.

 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.

 Linguistic

The Linguistic's interests are usually focused on ideas and information exchange. They tend to like reading a lot, and enjoy discussion about what has been said. Some will want to write about their own ideas and may follow a path towards journalism, story writing or editing. Others will develop skills in other languages, perhaps finding work as a translator or interpreter. Most Linguistic types will enjoy the opportunity to teach or instruct people in a topic they are interested in.

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

Sample Education and Training Pathways
A number of courses are available throughout the country that focus on learning and skills that may be useful for this career. The examples and links below may guide you in your research. 

Further Education (FET)
Further Education & Training (FET) Courses are delivered by local ETBs, ranging in duration from several weeks up to 20 months. Courses are designed to meet the labour market needs and often include a large element of work experience.

Example search terms include: business admin, customer service, quality management, quality assurance.

Search for FET Courses

PLC Courses (FET)
PLC courses are full-time courses, one or two years duration, with awards at Level 5 and 6 on the NFQ. They are offered nationally in Schools and Colleges of Further Education.

Example search terms include: business management, sales, marketing, commerce, compliance, data management, accounting.

Search for PLC Courses

Apprenticeships: 
Apprenticeships are structured work-based training programs that combine on-the-job training with classroom instruction. They run from 2 – 4 years and are open to individuals of all ages, including school leavers, those seeking a career change, and existing employees who wish to upskill.

Examples: Accounting, Finance, Sales, Lean Sigma Management.

Search for Apprenticeships

Higher Education CAO (Undergraduate)
Higher Education courses at Levels 6 to 8 on the NFQ, delivered in Universities and Technological Universities & Institutes. Courses run from 2 – 5 years and places are allocated on a points-based system, processed by the Central Application Office.

Example search terms include: business, commerce, law, economics, maths, statistics, accounts, finance.

Search for CAO Courses

Higher Education (Postgraduate)
Postgraduate courses are courses at Levels 9 and 10 on the NFQ and usually last 1 – 2 years full time, or longer if a PhD or part time. Entrants typically require an undergraduate award (Level 8).

Example search terms include: sales, business, accounts, management, financial, regulatory compliance advice, global trade compliance, governance compliance, data protection, financial services, medical technology, regulatory affairs.

Search for Postgraduate Courses

Salary Range (thousands per year)* €45k - €90k

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

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

Last Updated: July, 2024

Note: The following information relates to occupations that include: Design and development engineers; Production and process engineers; Quality control and planning engineers; Quality assurance and regulatory professionals; Environmental health professionals.

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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