Reshape Your Medical Device Regulatory Career With British BioMedicine Institute
A medical device is any device intended to be used for medical purposes. What differentiates a medical device from an everyday device is its intended use. Medical devices benefit us by helping health care providers diagnose and treat us or by helping us overcome sickness or disease, improving our quality of life.
Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. The medical device industry plays a key role in the healthcare ecosystem by providing innovative solutions that improve patient outcomes.
Every company seeks to innovate, whether through iterative updates to existing technology or by developing new devices that could offer a more effective treatment to a particular disease or condition. Regulatory affairs professionals serve a critical function throughout a medical device’s product lifecycle—leading premarket strategy, drafting regulatory submissions, and ensuring postmarket compliance.
Many countries throughout the world have their own medical device regulations, however, and regulatory affairs is required to understand the differences in global regulatory requirements to ensure that new products can be marketed.
By cultivating a collaborative relationship between regulatory affairs and all other departments within the organization, medical device companies will be better able to protect themselves, their resources, their customers and ultimately the patients who benefit from the device. The global regulatory landscape is always changing, so successful regulatory affairs teams follow global trends and are aware of new regulations or programs.
Today, the determining factors for whether a device qualifies for 510(k) or pre-market approval (PMA) submission have gotten much more stringent and convoluted. If the device concept is indeed novel, it is unlikely to have a predicate (or may be significantly different from the most comparable device), which means that it wouldn’t qualify for 510(k) submission.
Instead, the FDA would require the device be submitted as a PMA. To move the submission process forward, the company first would have to spend millions of dollars in clinical trials and years getting it through the PMA process. With this information, the future growth team is likely to abandon the project. Had RA been involved in the team’s conversations from the outset, all of that time and money could have been saved.
Regulatory professionals often are referred to as “police” in today’s global medical device marketplace, and much like local law enforcement, regulatory affairs’ job is to two-fold: Protect the medical device manufacturer from getting into trouble with the authorities regulating them; and serve the needs of all stakeholders by helping to ensure that the company gets safe, reliable products to market efficiently and cost-effectively—without any barriers to clearance. To adequately do their job, RA must be included in the conversations that take place at each stage of the device’s life cycle.
The global medical devices (MD) market will see a steady growth over the coming years with the sales revenue and international trade value expected to exceed $570 billion and $380 billion respectively by 2022 driven by aging population, increasing healthcare expenditure and technology advancement. By involving RA in every key device-related meeting and decision; allowing them to review designs early; and collaborating with RA on test plans, reports, and timelines, medical device manufacturers will be better able to succeed with their innovations and with their business.
✔️Work with the Head of QA/RA and business streams to identify regulatory requirements for projects and territories
✔️Collaborate with product and engineering teams to ensure all products meet the applicable regulatory requirements and develop and maintain technical files for Medical Device Software (MDSW)
✔️Advise company of Regulatory changes affecting the Business, Quality Management and medical devices
✔️Implement these changes where necessary i.e. MDR
✔️Manage the Risk Management programme in line with ISO 14971
✔️Control and keep up to date the Risk Management Files and Clinical Evaluation reports for each Technical file
✔️Ensure the appropriate regulatory requirements are fulfilled for all products
✔️Write and edit technical documents
✔️Supporting the implementation and management of the eQMS systems
✔️Supporting the QA/RA Lead with the management of the QMS
✔️Supporting/mentoring the QA Associate and providing development opportunities
✔️Ability to prioritise workload in a start-up environment across different projects
✔️Experience in medical device regulatory affairs including knowledge of reporting and vigilance requirements in different territories
✔️Comprehensive understanding and training with ISO14971 Risk Management
✔️Good working knowledge of GDPR and DPA & experience with IG requests such as DPIA
✔️Understanding of the requirements for Clinical Evaluation according to MEDDEV 2.7.1 Rev 4 and the changes under the MDR
✔️Ability to solve regulatory problems in new and innovative ways
✔️Experience of start-up culture and ways of working is beneficial
✔️Excellent verbal and written skills
✔️Ability to prioritise workload in a fast-paced environment
✔️Self-starter – to be able to hit the ground running and lead the build of Huma in a new market
✔️Roll up your sleeves – you are the backbone of the company and underpin our delivery and successes
✔️Self Solver – seek solutions through collaboration
✔️Sense of urgency – to be able to focus your energy on where it matters the most
✔️Vision – imagine what is possible, and drive our business forward
✔️A product evangelist who naturally engages others