Sr Regulatory Affairs Specialist (F/M)

The International Diabetes Federation estimates at 415 million the number of people living with Diabetes - one in eleven! - and predicts that this number will grow and reach 642 million in 2040.

Glycemic control is an essential part of diabetes management, aiming to avoid short and long-term complications associated with the condition. Glycemic control must therefore be measured in a rigorous and reliable way on a daily basis, in order to support the multiple decision-making specific to the management of the condition and maintain blood sugar levels in the desired levels.

With the availability of continuous glucose monitoring systems, aiming to provide users continuous visibility on their blood sugar level to optimize their treatment and improve their quality of life, diabetes management is entering a new era. And despite recent advancements, current available products still have some important shortfalls in helping people living their life with diabetes, not the other way around. And this is at the core of Metronom Health’s mission and vision, consisting of developing and designing a new continuous glucose monitoring system, aiming at making diabetes a smaller part of life.

Our disruptive technology aims at providing people living with diabetes and those caring for them with an accurate, reliable, user friendly and affordable continuous glucose monitoring system. Our CGM (Continuous Glucose Monitoring) system aims at significantly reduce both the short-term and long-term health complications associated with uncontrolled or poorly managed blood glucose levels, whilst improving the day to day quality of life of people living with diabetes.

A first in Human proof on concept study has been completed successfully, and we are now fully engaged in the development of the commercial product, targeting a market release in Europe by 2021.

It's time to reinforce our californian team. We are currently looking for a talented

Sr Regulatory Affairs Specialist (F/M)

The Sr. Regulatory Affairs Specialist is responsible for supporting the development and submission of the next generation Continuous Glucose Monitor (CGM) being developed by Metronom Health. This is a startup environment and the candidate must be very high energy, flexible and able to keep up with a fast-paced environment. The primary responsibilities include: supporting US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.  

Duties and responsibilities

• Support and lead elements of FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.
• Provide support with Quality/Regulatory Team and international team to provide regulatory support for new products. Work with quality, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Support submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings.
• Represent RA function for EU MDR, including leading and prioritizing technical documentation requirements
• May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Ensure personal understanding of all quality policy/system items that are personally applicable.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Other duties as assigned.

Requirements:

• Minimum of a Bachelor’s degree
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
• 5+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
• 3+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Master’s degree.
• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III)
• Experience with 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances. 
• Experience with IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files, 30-day Notices, and Real Time Reviews
• Experience with regulatory support of clinical trials
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
  
• Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.
• Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
  
• Ability to compile data and summarize results
• Organized, efficient, process-oriented; high attention to detail
•  Effective interpersonal/communication skills
• Ability to effectively manage multiple projects and priorities
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

If you are passionate and looking for a challenge, contact us and let’s discuss!