Biotech Research Group is a scientific and regulatory consulting firm located in Tampa, Florida, position can be remote. Our firm serves clients around the globe in the pharmaceutical, biologics and medical device industries. We have an opening on our team for someone who can primarily provide regulatory submission services to our clients both in the medical device and pharmaceutical arenas. The ideal candidate will have expertise in a multitude of regulatory submission types, including pharmaceuticals with a strong background in the medical device industry.
Summary of Position:
You have the opportunity, to join Biotech Research Group as a Regulatory Expert and be part of a talented and dynamic team. In this important and exciting role, you will be responsible for executing US regulatory submissions for our medical device and pharmaceutical clients. Reporting directly to the CEO, you will lead and work independently with projects. If you are a RAPS professional who is looking to work remote or work in Tampa, this could be the perfect opportunity for you!
Specific Job Responsibilities:
Act as a team player– someone who is positive, forward-looking, accountable, action-oriented, and focused on delivering results
Provide expertise to develop and implement complex regulatory strategies throughout the product lifecycle that are consistent with goals and objectives
Prepare and review FDA submissions and other regulatory documents including Pre-Subs, 510(k)s, Special 510(k)s, PMAs, PMA Supplements, PMA Amendments, De Novo, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications, MDRs, and various annual, periodic, and/or study reports
Strategize and develop regulatory plans and documents for products, product updates, manufacturing process changes, marketing materials, and clinical trials
Assess and review client’s medical device files for regulatory requirements mainly for US and European markets
Utilize knowledge of regulatory requirements applying to manufacturers’ processes and products
Review product design, documenting any deficiencies, review engineering and manufacturing
Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills
Respond to inquiries immediately
Acquire new accounts
Work with minimal supervision while obtaining project objectives
Possible travel depending on project
Supports product recall and removal planning, execution, and tracking
Maintains current knowledge of FDA medical device regulations and guidances
Lead with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF
Minimum of 10 years of experience with Medical Device industry and directly working with and being responsible for Regulatory Affairs/Submissions to FDA (additionally, EU submissions helpful)
Thorough knowledge and demonstrated ability to successfully submit documents related to Pre-Subs, 510(k)s, Special 510(k)s, PMAs, and De Novo requests
Knowledge of engineering and technical applications used in the development of medical devices is helpful
Excellent interpersonal, verbal, written and presentation skills. Must work well in project teams
Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills
Pro-active attitude and excellent organizational skills and the ability to work autonomously
Experience with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF
2 openings. Telecommuting is allowed.
Additional Salary Information: Bonuses with new procured accounts
Internal Number: RE
About Biotech Research Group
Biotech Research Group (BRG) is a full service regulatory and product development consulting firm. BRG has an excellent reputation as a leading regulatory and scientific affairs consulting firm, which has clients and consultants in over 60 countries across the globe. The primary aim of BRG is to provide efficient and expeditious services and give the best solutions for our clients’ products that include pharmaceutical consulting, medical devices, healthcare information technology, and scientific services.