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Medical Device Regulatory Affairs Compliance is the Key to success as FDA regulates the Industry.
The medical device industries work in tandem with the pharmaceutical industries by providing innovative solutions to improve patient outcomes. The companies either innovate by updating the existing technology or developing a new device. These devices provide a means for the effective treatment of a particular disease or condition. A regulatory affairs professional performs a critical role in the medical device lifecycle-right from the innovation of the device to the device reaching the physician. It includes medical device compliance training, leading premarket strategy, drafting regulatory submissions, and ensuring post-marketing compliance. As all of these activities are scrutinized, it demands a professional with a specific set of skills. If you wish to set your foot in this domain, here are the skills you need to watch out for:
1. Regulatory Knowledge
Usually, a degree in any field of science with regulatory affairs medical device courses may pave the way into entry-level jobs in regulatory affairs. To become a regulatory specialist, however, you need to have a strong theoretical knowledge of various legislations governing medical products as well as an understanding of the technical aspects involved in regulatory submissions.
2. Eye for Detail
Being a regulatory professional, you will have to parse through and review thousands of pages of documents. Furthermore, you will also have to ensure that these documents are following legal, business, and pharmaceutical protocols. Many times, regulatory specialists also draft their detailed documents to evaluate protocols. This complex review process is hectic and being able to understand the process requires an eye for detail.
3. Critical Thinking
Keeping a close track of regulatory changes, analysing its implications on drug development, and the authorization process is part of a regulatory affair professionals life. The professionals should be able to synthesize complex information and convert it in a comprehensible manner for the people to understand.
4. Knowledge of Business, Law, and Science
Regulatory affair is a beautiful amalgamation of business, law, and science. The regulatory professional is involved at every step of the drug development process, right from the initial idea till its market arrival. This big journey makes the professional juggle through different fields at one time. Hence, aspiring regulatory affairs professionals are required to have a strong understanding of these business, law, and science.
5. Writing Skills
If you are someone who doesnt like to write, perhaps regulatory affairs are not for you! With regulatory affairs, you will get to write, and review hundreds of documents. You will also be involved in diligence reviews, review of protocols, reports, and every type of regulatory documentation with regards to quality, safety, and efficacy. All of this will require strong subject matter knowledge, linguistic skills, and information about different regulatory, legal guidelines to convert into structured templates.
6. Passion to Help People
Medical Device Manufacturers hire regulatory affairs specialists or outsource their requirement to professional experts to make sure the device is approved faster for marketing authorisation. Medical device companies have fast tracked their hiring process in regulatory affairs with a aim to keep operation smooth and efficent and get the product to market at the earliest. Medical Device reaching the consumer fast helps both the company in terms of revenue and at the same improved the lives of the patients.
7. Oral Communication
Sometimes, regulatory affairs professionals have to represent both internal and external parties and also conduct medical device regulatory affairs training. Hence, they are required to speak clearly and persuasively in all possible situations. An effective communicator may help in establishing strong relations with regulatory authorities, the marketing department, manufacturing sites, and other relevant technical functions. On top of it, having fluency in another language is also considered an asset.
8. Organizing Skills
A day in the life of a regulatory affair specialist can never be predicted. It involves a wide range of tasks from advising to coordinating application procedures for the approval of medical devices. Sometimes, these tasks are detail-oriented and demand a realistic action plan. This action plan can only be followed by prioritizing work activities otherwise it may end up creating a huge pile on the desk. Hence, to become an efficient regulatory affair professional, you should be able to manage and organize a lot of tasks in one go.
9. Business Skills
It is extremely important for regulatory affairs professionals to also have business skills that can be employed in a sound business strategy. At a higher level of the career ladder, the regulatory affairs professionals have to make critical decisions based on their judgements in finance, marketing and policy while complying with regulatory intelligence, and guidance.
To Sum It Up Regulatory affair in the medical device industry is a vast domain. The aspiring candidates should know various fields and develop attention to detail to succeed in the domain. Furthermore, you can also enrol yourself in medical device training courses to have in-depth knowledge about the field. Apart from this, work on the above skills and pave your way into this amazing field.
