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Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Job Summary
The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factorys Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies and plans throughout the lifecycle of the SaMD products.
This role acts as a subject matter expert that helps to ensure compliance with applicable international regulations in which the company does business; preparing product regulation plans and submission documentation for international markets and evaluating product changes for effects on regulatory license registrations.
Responsibilities:Key Accountabilities (Digital Factory Products)
Networking/Key Relationships
Minimum Knowledge & Experience required for the position:
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
Advanced knowledge of FDA, MDSAP, IVDR, MDR and international regulations, as well as ISO 13485 and other international standards
Travel Requirements:
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individuals race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
Full Time
$80k-104k (estimate)
05/28/2024
06/15/2024
werfen.com
Bedford, MA
<25
The following is the career advancement route for Principal Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Principal Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Principal Regulatory Affairs Specialist. You can explore the career advancement for a Principal Regulatory Affairs Specialist below and select your interested title to get hiring information.