A company is looking for a Global Regulatory Affairs Specialist. ...
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...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. Provides guidance on regulatory requirements necessary for strategic an...
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...
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. Perform regu...
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 ...
Senior Regulatory Affairs Specialist - (Medical Device) - ONSITE position in. Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues. If you would like to learn more about this Regulatory Affairs Specialist opportunity, apply directly or reach o...
The Public Policy and Regulatory team exists to further the interests of our community of hosts and guests with politicians, regulators, opinion leaders and others who shape the political and legal context for our business, helping them to understand the significant social and economic contributions...
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...
The Regulatory Affairs Specialist will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. Perform regulatory asses...
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...
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. Senior Regulatory Affairs Specialist. Assist in the development of regional regulatory strate...
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...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Senior Regulatory Affairs Specialist . Senior Regulatory Affairs Specialist. Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team. ...
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...
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...
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...
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...
Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company,. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Participating in setting regulatory operation process, including the regulatory document ...
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...
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...
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, ...
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...