As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Da...
A company is looking for a Global Regulatory Affairs Specialist. ...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
A company is looking for a Senior Clinical Regulatory Specialist. ...
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global. Perform regulatory assessments for product changes including regulatory reportability decisions. Work with cross functional team and international regulatory colleagues to develop an...
A company is looking for a Regulatory Specialist in the US. ...
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance ...
Regulatory Affairs Specialist III in Pleasanton, CA. Your main responsibilities as a Regulatory Affairs Specialist III:. May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer...
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Regulatory Affairs Specialist– Santa Clara, CA. Assi...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Key job respon...
As a Senior Regulatory Affairs Specialist, Medical Devices at Verily, you will work directly with other Regulatory Affairs team members, partners, and a team of experts from diverse fields (eg, Biology, Chemistry, Physics, Electrical Engineering, Computer Science) to develop, manage and execute regu...
The Principal Regulatory Affairs (RA) Specialist will work with the team to support the Regulatory Affairs department to ensure the overall regulatory compliance with the applicable regulatory bodies and ensure compliance with the Presidio Quality Management System (QMS). The Principal Regulatory Af...
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of o...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval. Develop and maintain positive relationship...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory...
Senior Staff Regulatory Affairs Specialist. Senior Staff Regulatory Affairs Specialist. You will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development and submission. Serve as a regulatory affairs representative to improve awareness, ...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...