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Our client is an established Medical Device Manufacturer that has been in business for many years. They seek a Regulatory Affairs Manager that will report to their US Head of Regulatory. Their site has over 300 employees, with a total of 225 throughout North America. This is a new position due to continued growth and product development.
The Regulatory Affairs Manager will be a key member within the organization, providing provide regulatory oversight of compliance for cosmetics products.
Our client is an established Medical Device Manufacturer that has been in business for many years. They seek a Regulatory Affairs Manager that will report to their US Head of Regulatory. This is a new position due to continued growth and product development.
As a Regulatory Affairs Manager, you will be responsible for supporting global regulatory submissions and ongoing regulatory compliance through the product development lifecycle. This role would be a great opportunity for someone who is looking to take the next step in his or her career and requires strong attention to detail, as well as comprehensive knowledge of the regulatory applications process for EU and FDA regulations.
The Director of Regulatory Affairs will be responsible for administering our clients' regulatory function in accordance with company, FDA, and Health Canada requirements. You'll be developing associated regulatory procedures in close collaboration with the Sr. Director, NAM Regulatory Affairs and Quality, as well as with corporate regulatory and quality teams.
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When you’re working Regulatory Affairs Manager jobs, Regulatory Affairs Director jobs, as a Regulatory Affairs Manager, Senior Regulatory Affairs Manager, or Regulatory Affairs Project Manager, you’ll take on the role of diligently monitoring your company or organization’s production activities to ensure compliance with various applicable regulations and standard operating procedures. In Regulatory Affairs Manager jobs, you’ll oversee regulatory submissions, making sure they accurately and completely comply with regulations dictated by government bodies and other entities. You’ll prepare and file the submission documents and assist with external audits to ensure compliance. You will also respond to any potential complaints regarding devices and products. Finally, you’ll manage a team or teams who will assist you in achieving any and all regulatory endeavors by monitoring their performance and output to ensure your company or organization’s continued success.
Regulatory Affairs Manager Roles and Responsibilities
Regulatory Affairs Manager Skills and Qualifications
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