Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Description: 100% REMOTE
The Regulatory Affairs Specialist is responsible for implementing global product Regulatory strategies and processes focused on ensuring compliant, timely, and cost-effective submissions to get needed licenses, registrations, and listings for medical devices and drugs.
Key Responsibilities:
• Lead timely execution of Regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products
• Assist with providing leadership to global business in the preparation of regulatory submission documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner
• Assist with the development of effective long and short-term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations
• Ensure accuracy of Declaration of Conformity for EU in conjunction with Authorized Representative and provide support for medical device and drug classification in global markets
• Review product and labeling/claims changes to maintain regulatory compliance
• Maintain regulatory records by updating corporate databases, recording and filing appropriate regulatory registrations and submissions
• Ensure product labeling and claims are accurate, substantiated, documented, and compliant with applicable regulations
• Oversee and maintain site establishment registrations and certifications
• Monitor domestic and international regulatory development changes that may potentially impact the company’s products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actions
• Provide education and training on regulations to company employees, as needed
• Investigate and report to global regulatory authorities (as required) product complaints
Skills & Qualifications:
At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred.
• An experienced regulatory professional with 5 years of medical devices and associated regulatory experience
• 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs
• Experience supporting Class III PPE products
• Proven experience building effective relationships with the FDA and other international regulatory bodies including the EU and Health Canada
• Experience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodies
• Strong knowledge of global country-specific regulations required for registering and marketing products for sale in applicable countries
• Understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
• Must have excellent written and spoken English
• Excellent communication and organizational skills
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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