Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
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...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. Minimum of 5 years of experience in medical device Regulatory Affairs with a deep understanding of regulatory frameworks. As a key player in regulatory over...
The Executive Director/Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Executive Director/Senior Director of Regulatory Affairs. If you or someone y...
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. Contribute to continuous improvement initiatives within the regulatory affairs function. Experience with Japa...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
The Senior Compliance Analyst has advanced knowledge of the job area and technical systems and practices, and advanced technical skills and reporting abilities. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compli...
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. ...
Director of Regulatory Affairs. You’d oversee regulatory filings, partner with external consultants, and eventually build out the regulatory function internally. Partner with external regulatory consultants and oversee the build-out of the internal regulatory function. This role will be pivotal in b...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
The ideal candidate will bring maturity and expertise to our project management processes, ensuring that all projects are completed on time, within budget, and to the highest standards. Responsible for overseeing and managing facility-related projects from inception to completion. Lead and manage mu...
Program and Regulatory Specialist. The Energy Commission seeks a Program and Regulatory Specialist to fill one position in the Special Projects Unit within the Fuels and Transportation Division. Under general direction of a Program and Project Supervisor, the Program and Regulatory Specialist will s...
Regulatory Affairs Director required by Barrington James for an initial 12-month, remote contract opportunity with the client based in South San Francisco. ...
The Assistant Project Manager is responsible for facilitating the successful delivery of assigned projects from inception to close-out, on schedule, within budget, in accordance with the approved scope, meeting established quality requirements and objectives under the direction of the Acquisition Pr...
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...
You will work in close partnership with other Project Managers in the marketing organization towards overall alignment and efficiency in all marketing efforts. You will manage Demand Generation Projects from submission to completion including organizing communications and hand-offs between partners....
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...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...