Join us as we build a new department focused on revolutionizing the way things are done in our industry. We are performing cutting edge research and developing innovative tools to solve challenging problems. This role brings you the opportunity to firmly apply your stamp to our products, now and well into the future. Join us in creating amazing and functional experiences.
This role will own the process of developing and executing the company product safety and regulatory compliance program. Will successfully guide and support the development and release to market of multiple products that comply with industry and jurisdictional regulatory standards and codes.
What will you do?
Define product requirements necessary to achieve safety and regulatory compliance in all jurisdictions our products are intended to be sold.
Contribute to the product development effort to ensure our products meet applicable regulatory requirements.
Develop and lead the safety and EMC compliance program for products we manufacture and sell.
Establish positive relationships with safety and compliance agencies and vendors for regulatory tests going to Technical File.
Establish plans and work with Bio Product Division sites to achieve and maintain safety and EMC compliance for all company products.
Support all safety, regulatory, and sustainability compliance needs that arise during the production life of our products.
Will maintain all technical files and documents related to compliance.
Conduct Market Surveillance and appropriate collaboration activities to stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards.
Interpret how changes to existing regulations and emerging regulations impact bPD products, and ensure all BPD sites are informed and enabled to meet regulations on time and with appropriate documented evidence
Competence in determining test suites to achieve CE and NRTL (Nationally Recognized Testing Laboratory)
Experience and thorough understanding of applicable standards such as IEC 61010, etc.
Experience preparing manufacturing facilities for inspections.
Thorough understanding of global regulatory and safety requirements.
Excellent written and verbal communication and influencing skills
Willingness to travel domestically and internationally (less than 20%)
Knowledge of Global standards for EMC performance: EU Low Voltage Directive, EMC Directive and EMC standards a plus.
Experience with ESD, EMC and EMI testing (emissions & immunity) preferably on the design level. Ability to review designs and offer suggestions for improvements.
Should have excellent knowledge of international wireless standards pertaining to a broad range of electronic equipment, e.g. FCC, ETSI, Wi-Fi, BlueTooth, etc
Must have knowledge or demonstrate ability to quickly gain knowledge of local and international certification processes and must be able to interact with all certification authorities
Must be able to handle multiple projects simultaneously to determine requirements and propose solutions
Demonstrated project management skills and ability to handle multiple simultaneous projects during development and production stages, across multiple sites.
Internal Number: 92409BR
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $ 24 billion and approximately 70,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.