In Summary - Regulatory Affairs Specialist
Regulatory Affairs Specialists typically work in the following Career Sectors:
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The Work - Regulatory Affairs Specialist
Most commonly reported Work Tasks
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- 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.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
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.
- Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
- Interacting With Computers Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
- Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
- Organizing, Planning, and Prioritizing Work Developing specific goals and plans to prioritize, organize, and accomplish your work.
- Processing Information Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
- Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
- Establishing and Maintaining Interpersonal Relationships Developing constructive and cooperative working relationships with others, and maintaining them over time.
- Making Decisions and Solving Problems Analyzing information and evaluating results to choose the best solution and solve problems.
Interests - Regulatory Affairs Specialist
This occupation is typically suited for people with the following Career Interests:
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.
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.
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.
Entry Requirements - Regulatory Affairs Specialist
Relevant degree areas include life, physical, mathematical, applied and medical sciences in areas such as:
- The life sciences
- Medicinal chemistry
- Biomedical science
- Chemical and physical sciences
The College of Science, School of Natural Sciences at NUIG offer an MSc. in Medical Technology Regulatory Affairs.
Last Updated: August, 2015
Pay & Salary - Regulatory Affairs Specialist
Salary Range (thousands per year)* 23k - 63k
Last Updated: March, 2017
* 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.