Careers rarely develop the way we plan them. Our career path often takes many twists and turns, with particular events, choices and people influencing our direction.

We asked Caitriona Jackman from Smart Futures to give some advice for people considering this job:

 

Caitriona Jackman

Planetary Scientist

Smart Futures

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  Caitriona Jackman
If you are considering full-time scientific research, try to get a work placement in a university department so you can see first hand what it’s like. It’s a relatively relaxed, flexible environment, but there is a certain degree of self-motivation needed. 

So I would say you need to be able to push  yourself and be proactive in terms of setting up collaborations with other scientists etc.
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Many will seek out positions where there is direct contact with the public in some advisory role, whether a receptionist or a counsellor. Social people are motivated by an interest in different types of people, and like diversity in their work environments. Many are drawn towards careers in the caring professions and social welfare area, whilst others prefer teaching and other 'informing' roles.
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Occupation Details

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Regulatory Affairs Specialist

Job Zone

Education
Most of these occupations require post-graduate qualifications. For example, they may require a masters degree, and some require a Ph.D., or M.D.

Related Experience
Extensive skill, knowledge, and experience are needed for these occupations. Many require more than five years of experience. For example, surgeons must complete four years of college and an additional five to seven years of specialised medical training to be able to do their job.

Job Training
Employees may need some on-the-job training, but most of these occupations assume that the person will already have the required skills, knowledge, work-related experience, and/or training.

Job Zone Examples
These occupations often involve coordinating, training, supervising, or managing the activities of others to accomplish goals. Very advanced communication and organisational skills are required. Examples include librarians, lawyers, aerospace engineers, wildlife biologists, school psychologists, surgeons, treasurers, and most scientists.

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At a Glance... header image


Tasks & Activitiesheader image

The following is a list of the most commonly reported tasks and activities for this occupation

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Coordinate, prepare, or review regulatory submissions for domestic or international projects.

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Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

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Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

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Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

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Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

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Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

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Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

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Prepare or maintain technical files as necessary to obtain and sustain product approval.

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Coordinate efforts associated with the preparation of regulatory documents or submissions.

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Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

Work Activities header image

The following is a list of the most commonly reported work activities in this occupation.

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Organizing, Planning, and Prioritizing Work:  Developing specific goals and plans to prioritize, organize, and accomplish your work.

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Updating and Using Relevant Knowledge:  Keeping up-to-date technically and applying new knowledge to your job.

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Getting Information:  Observing, receiving, and otherwise obtaining information from all relevant sources.

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Establishing and Maintaining Interpersonal Relationships:  Developing constructive and cooperative working relationships with others, and maintaining them over time.

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Communicating with Supervisors, Peers, or Subordinates:  Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

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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.

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Processing Information:  Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

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Identifying Objects, Actions, and Events:  Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

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Interpreting the Meaning of Information for Others:  Translating or explaining what information means and how it can be used.

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Communicating with Persons Outside Organization:  Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.


Knowledge header image

The following is a list of the five most commonly reported knowledge areas for this occupation.

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English Language:  Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

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Law and Government:  Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

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Clerical:  Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.

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Computers and Electronics:  Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

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Administration and Management:  Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.


Skillsheader image

The following is a list of the most commonly reported skills used in this occupation.

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Reading Comprehension:   Understanding written sentences and paragraphs in work related documents.

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Judgment and Decision Making:   Considering the relative costs and benefits of potential actions to choose the most appropriate one.

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Critical Thinking:   Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

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Speaking:   Talking to others to convey information effectively.

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Systems Analysis:   Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

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Writing:   Communicating effectively in writing as appropriate for the needs of the audience.

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Coordination:   Adjusting actions in relation to others' actions.

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Active Listening:   Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

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Systems Evaluation:   Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.

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Persuasion:   Persuading others to change their minds or behavior.

Entry Routesheader image

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

The College of Science, School of Natural Sciences at NUIG offer an MSc. in Medical Technology Regulatory Affairs.

Last Updated: August, 2015


Related Occupationsheader image

Contactsheader image

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Organisation: The Health Products Regulatory Authority
  Address: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
  Tel: (01) 676 4971
  Email: Click here
  Url Click here

 

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Career Guidance

This occupation is popular with people who have the following Career Interests...


...and for people who like working in the following Career Sectors:

Chemical, Biomedical & Pharmaceutical Sciences
Law & Legal

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