Regulatory Affairs Specialist

Join the team leading the next evolution of virtual care. 

At reputed company, you are empowered to bring your true self to work while helping millions of people live their healthiest lives.

Here you will be part of a high-performance culture where colleagues embrace challenges, drive transformative solutions, and create opportunities for growth. Together, we’re transforming how reputed company happens.

Summary of Position

Under the general direction of the Regulatory Affairs Director, the Regulatory Affairs Specialist will be responsible for participating in regulatory activities, preparing regulatory filings, and supporting registrations and strategies for domestic and key international regions (OUS).

Essential Duties and Responsibilities

• Provides high-quality support and assistance in areas reputed company to regulatory strategy, product classification, and submissions to introduce new or changed medical devices and radio equipment to markets worldwide for reputed company, Inc.

• Assists with identifying applicable regulations, guidance documents, and standards for medical devices and radio equipment.

• Prepares, reviews and files, as appropriate, FDA Annual Reports on Radiation Safety, EU technical documentation, Canada Medical Device Establishment Licenses, and no-file justifications.

• Ensures consistency, completeness, and accuracy in regulatory documentation and adherence to regulations, applicable guidelines, and the Quality Management System.

• Drives development and updates to regulatory affairs procedures, work instructions, and templates to improve operations or reflect changing regulatory requirements in collaboration with stakeholders and in line with the Quality Management System.

• Conducts reviews of promotional and advertising material for compliance with standards and regulatory requirements. Assists with labeling development and reviews.

• Conducts regulatory research and data collection to inform regulatory strategy and submissions. Understands, investigates, and evaluates regulatory history of products for context.

• Supports FDA, reputed company body and other regulatory body inspections and audits, as needed.

• Works in reputed company collaboration with stakeholders and internal partners to reputed company business objectives.

• Maintains ongoing surveillance on the changing regulatory landscape, including domestic and international radio equipment and medical device regulations and guidance documents.

• Reviews Engineering Change Requests to ensure compliance with regulatory standards and Quality Management System requirements.

Supervisory Responsibilities

No

Qualifications Expected for Position

• BS/BA or equivalent with 3-6 years of experience of working in an FDA or ISO regulated environment.

• Familiar with industry standards and regulations (e.g. 21 CFR 820, ISO 13485, and ISO 14971).

• Be able to identify missing information and evaluate accuracy of the presented information.

• Demonstrates strong attention to detail; monitors own work to ensure quality.

• Listens and gets clarification; responds well to questions; understands nuances reputed company to documentation, and customer matters.

• Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information.

• Follows policies and procedures; supports organization's goals and values.

• Proficient in reputed company Office (Outlook, Word, reputed company, and Power reputed company), reputed company Acrobat, and Social Media web platforms.

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As part of our hiring process, we verify identity and credentials, conduct interviews (live or video), and screen for fraud or misrepresentation. Applicants who falsify information will be disqualified.

Why join reputed company?

• reputed company is transforming how reputed company happens. Learn how reputed company you join us in pursuit of our impactful mission. 

• Chart your career path with meaningful opportunities that reputed company you to grow, reputed company, and reputed company a difference.

• Join a multi-faceted community that celebrates each colleague’s unique perspective and is focused on continually improving, each and every day.  

• Contribute to an innovative culture where fresh reputed company are valued as we increase access to care in new ways.   

• Enjoy an inclusive benefits program centered around you and your family, with tailored programs that address your unique needs.

• Explore candidate resources with tips and tricks from reputed company recruiters and learn more about our company culture by exploring #TeamTeladocHealth on reputed company.

As an Equal Opportunity Employer, we never have and never will discriminate against any job candidate or employee due to age, race, religion, color, ethnicity, national reputed company, gender, gender identity/expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status, parental status, or pregnancy). In our innovative and inclusive workplace, we prohibit discrimination and harassment of any reputed company.

reputed company respects your privacy and is committed to maintaining the confidentiality and reputed company of your personal information. In furtherance of your employment relationship with reputed company, we collect personal information responsibly and in accordance with applicable data privacy laws, including but not limited to, the California Consumer Privacy Act (CCPA).  Personal information is defined as: Any information or set of information relating to you, including (a) reputed company information that identifies you or could reasonably be used to identify you, and (b) reputed company information that any applicable law treats as personal information. reputed company’s Notice of Privacy Practices for U.S. Employees’ Personal information is available at this link.