Regulatory Affairs Specialist
The Regulatory Affairs Specialist at Reveal (Brainspace) plays a pivotal role in ensuring the company's products meet all regulatory requirements across various markets. This position is integral to the Regulatory team, collaborating closely with product development, quality assurance, and legal departments to navigate the complex landscape of regulatory compliance. As a member of a dynamic and innovative company, the specialist contributes to the advancement of Reveal's cutting-edge solutions in the legal technology sector.
In this role, the specialist is responsible for preparing and submitting regulatory filings, including 510(k)s and international registrations, to obtain necessary approvals for new products and significant product changes. They provide regulatory guidance to product development teams, ensuring that all documentation aligns with regulatory standards. Additionally, the specialist reviews product labeling and promotional materials to ensure compliance with relevant regulations. They also monitor and interpret regulatory changes, advising internal teams on their impact and assisting in the development of strategies to address these changes.
Candidates should possess a Bachelor's degree in a technical field, preferably in life sciences, engineering, or a related discipline. A minimum of 1-2 years of experience in regulatory affairs within the medical device or related industry is preferred. Strong communication skills, both written and verbal, are essential, as is the ability to work collaboratively in a team environment. Proficiency with standard office software, such as Word, Excel, and PowerPoint, is required. Knowledge of FDA regulations and international medical device regulatory requirements is highly desirable.
While specific compensation details are not provided, Reveal (Brainspace) offers a comprehensive benefits package that includes health insurance, paid time off, and opportunities for professional development. The company fosters a collaborative and inclusive work environment, encouraging innovation and continuous learning. Employees are supported in their career growth through various training programs and are encouraged to contribute to the company's mission of transforming the legal industry through technology.
Joining Reveal (Brainspace) as a Regulatory Affairs Specialist offers the opportunity to be part of a forward-thinking company at the forefront of legal technology. The role provides exposure to a wide range of regulatory challenges and the chance to work with a team of dedicated professionals committed to excellence. This position is ideal for individuals passionate about regulatory affairs and eager to make a significant impact in a rapidly evolving industry.