Medical Device Regulatory Affairs (MDRA) Specialists assist in obtaining and maintaining government approval for medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies. They may also work in government or law. The duties and responsibilities of MDRA Specialists have expanded in recent years as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving regulations. The regulatory affairs industry oversees the development of foods, drugs, and medical products. Products are certified in meeting standards satisfactory for human use throughout the process of development, testing, manufacturing, marketing and distribution by specially-trained professionals.
- knowledge, skills, and experience in a subfield of the industry
- Learn the regulations that apply to the products in said subfield
- Learn how to apply the regulations to chosen subfield and its products
- Become a member of a regulatory organization
MDRA specialists play a vital role in the well-being of the global population by monitoring the development and distribution of safe, healthy foods and technological advancements in medicine. Typically, individuals in these positions work within an office of regulatory affairs where they work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments. Part of their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. MDRA is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
MDRA Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. In addition, they determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
A variety of job titles may be used in this profession, including Clinical Quality Assurance Associate or Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator or Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, and Regulatory Affairs Associate.
The scope of activities of a regulatory affairs specialist varies depending upon the context in which one works. Some typical job tasks include:
- Explain regulations, policies, or procedures
- Coordinating compliance documentation
- Examining product information
- Updating legal or regulatory knowledge
- Evaluating laws and regulations
- Explaining regulations, policies or procedures
- Maintain data in information systems or databases
- Ensure compliance with regulations
- Advise others on regulatory and compliance matters
- Evaluate applicable laws and regulations to determine impact on company activities
- Provide technical review of data or reports
- Coordinate regulatory documentation activities
- Identify and interpret relevant regulatory guidelines Overseeing business processes
- Obtaining authorization for activities
- Communicating with government agencies
- Maintaining data systems and databases
- Establishing organizational policies and guidelines
- Examining financial records and processes
- Preparing financial documents
- Training personnel
- Corresponding with customers
- Monitoring business indicators
- Analyzing environmental regulations
MDRA Specialists must be able to work in a demanding environment where strict timelines and protocols must be met. They frequently work on managing and documenting information, and must be adept at working with databases and other information management tools. Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions are full time. Some may work in contractor or consultant roles associated with a specific product. Others may be longer-term roles covering a wider array of products. Since they need to keep up to date on their area of expertise, attendance at professional conferences or relevant training events is common.