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Colm Hofler

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  Colm Hofler
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Occupation Details

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Regulatory Affairs Manager

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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Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

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Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

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Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

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Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

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Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

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Manage activities such as audits, regulatory agency inspections, or product recalls.

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Develop regulatory strategies and implementation plans for the preparation and submission of new products.

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Provide responses to regulatory agencies regarding product information or issues.

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Maintain current knowledge of relevant regulations, including proposed and final rules.

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Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

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

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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.

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

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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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Resolving Conflicts and Negotiating with Others:  Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

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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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Provide Consultation and Advice to Others:  Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.


Knowledge header image

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

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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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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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Medicine and Dentistry:  Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.

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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.

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Biology:  Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.


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

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

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Speaking:   Talking to others to convey information effectively.

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Monitoring:   Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

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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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Operations Analysis:   Analyzing needs and product requirements to create a design.

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Management of Personnel Resources:   Motivating, developing, and directing people as they work, identifying the best people for the job.

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

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