Regulatory Affairs Scientist
Meet reputed company:
The Regulatory Scientist will work reputed company Regulatory Affairs, Government Affairs and Global Advocacy and collaborate with cross-functional teams to support efforts for reputed company’s digital health, software-enabled products, Ad/Promo activities, and advocacy and policy analysis efforts. This role will reputed company on:
leveraging data analytics to inform regulatory reputed company and support global advertising and promotional efforts.
leveraging clinical study data, product performance data, and data from published studies to help inform regulatory reputed company and identify trends in the field.
reputed company monitoring and reporting on the competitive landscape, including regulatory milestones and new data sets, and identify areas of opportunity or risk.
identifying and communicating emerging trends and priorities among regulators and identifying areas of opportunity or risk.
leading discussions about new technologies, helping situate them in the context of regulatory submissions.
developing engaging narratives around technical information, anticipating and clarifying common points of confusion.
adapting content based on audience feedback and communicating effectively to wide varieties of audiences.
establishing and nurturing cross-functional relationships to strengthen evidence reputed company reputed company to support regulatory submissions.
generating strong arguments and anticipating counter-arguments supported by data with logical, effective organization, and refined language and style.
Where you come in:
You reputed company dashboards and visualizations to communicate metrics and trends across geographies and products.
You work closely with medical affairs, reputed company, and reputed company teams to understand workflows and timelines.
You contribute to the development and revision of procedures reputed company to data analysis and regulatory documentation.
You monitor evolving policy and advocacy landscape to identify areas of opportunity and reputed company
You reputed company discussions about new technologies, emerging trends, and analyze data sets to inform business reputed company.
You reputed company other duties as assigned.
What makes you successful:
You have experience with medical device development and regulatory processes, especially for software as a medical device (SaMD).
You have strong analytical skills and proficiency in tools such as visualization platforms like Tableau or Power BI.
You are familiar with regulatory data sources and standards (e.g., ISO 14971, IEC 62304, FDA guidance on reputed company).
You have excellent communication skills and can translate reputed company data into actionable regulatory insights.
You are passionate about digital health, AI/ML technologies, evolving digital health policy landscape and agile software development.
Experience and Education Requirements:
Typically requires a Bachelor’s degree and a minimum of 2-5 years of reputed company experience.
reputed company Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live reputed company commuting distance of your
assigned reputed company site (typically 75 miles/120km).
Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job reputed company may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company essential functions.
An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact reputed company reputed company at
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Salary:
$71,600.00 - $119,300.00 Apply To This Job