Senior Regulatory Affairs Specialist. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides mentoring and leadership to Regulatory Specialist I and II team members. Master’s Degree in Re...
Seeking a Principal Regulatory Affairs Specialist to support the Kindeva business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by:. Managing regulatory compliance activities for Kindeva and existing customer products and registrations as requ...
R&D Regulatory Specialist (Remote). Your main responsibilities as a R&D Regulatory Specialist (Remote):. What we are looking for in a R&D Regulatory Specialist (Remote):. Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products...
Regulatory Affairs Operations Specialist II. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specif...
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Updates all databases and regulatory binders with information pertinent to studying milestone progress. Maintains communicati...
Maintain or create technical/regulatory documentation such as IL, QIL, QF and SDS. Review artwork for fill weight claims, ingredients and regulatory issues. Assist with developing technical documents for new/existing products to meet regulatory and customer needs. High school Diploma or GED and 1-3 ...
Clinical Research Regulatory Specialist. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Updates all databases and regulatory binders with information pertinent to studying ...
Senior Regulatory Affairs Specialist. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides mentoring and leadership to Regulatory Specialist I and II team members. Master’s Degree in Re...
Youll also have access to:Career development with an international company where you can grow the care Operations Specialist, Regulatory Affairs, Operations, Regulatory, Specialist, Communications, Manufacturing, Healthcare. ...
Kitsch is looking for a highly skilled and knowledgeable Regulatory Compliance Specialist to become an integral part of our enthusiastic Quality team. The role is expected to work closely with our team of product development, production, purchasing, marketing, sales and vendors to conduct product ev...
The Opportunity Our location in Sylmar, CA currently has an on-site opportunity for a Senior Regulatory Affairs Specialist with our Cardiac Rhythm Management division. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulation...
To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain ...
Regulatory Affairs Specialist II. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agenc...
In this dynamic role as a Senior Regulatory Affairs Specialist, you will be responsible for informing both local and global regulatory partners of sustaining changes through the Medtronic Agile system. Regulatory writings for change notifications to local/global regulatory bodies and review regulato...
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Experience with Japanese and Chinese regulatory submissions. Ability to interpret and apply regulatory requir...
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...
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...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Role Kitsch is looking for a highly skilled and knowledgeable Regulatory Compliance Specialist to become an integral part of our enthusiastic Quality team. The role is expected to work closely with our team of product development, production, purchasing, marketing, sales and vendors to con...
R&D Regulatory Specialist (Remote). R&D Regulatory Specialist (Remote):. R&D Regulatory Specialist (Remote):. Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products. ...
My client is seeking a Regulatory Specialist to join our growing team. As a Regulatory Specialist, you will play a crucial role in ensuring our medical devices comply with global regulations. Develop and implement regulatory strategies to obtain timely approvals from worldwide regulatory bodies. Pre...
Regulatory Affairs Operations Specialist II. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specif...
A medical device client of ours in the East Bay Area is looking to bring on a Regulatory Affairs Specialist IV position!. Years of Regulatory Affairs experience across the medical device space. International Regulatory Affairs Experience Required (Europe specifically). ...