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...
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...
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 Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. Creates and imp...
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. Regulatory Affairs Special...
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. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. Creates and imp...
The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. Creates and imp...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company-Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced-Technical wri...
Regulatory Affairs Specialist II. 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. ...
This Associate Director of Regulatory CMC will directly report to the Senior Director of Regulatory Affairs, CMC, and will be responsible for representing regulatory CMC on cell therapy pipeline + products. Associate Director, Regulatory Affairs CMC. Regulatory Affairs CMC experience in a pharma/bio...
As a Regulatory Affairs manager, you will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. Regulatory Affairs, FDA, regul...
As the Director of Regulatory Affairs, you will be a pivotal leader within the company, driving strategic regulatory decisions across the entire portfolio. Director of Regulatory Affairs. You’ll co-lead a growing regulatory team, and play a key role within regulatory submission and strategy. Regulat...
This Senior Director/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. Senior Director/Director of Regulatory Affairs. Regulatory Affairs experience in a pha...
Associate Director Regulatory Affairs (Temp to Perm). Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards. Regulatory Affairs, including. Lead regulatory strategy development and execution for both U. ...
Director of Regulatory Affairs - Full Time - Onsite/Hybrid/Remote. The Director will work closely and report to the Head of Regulatory Affairs. Work closely with the Head of Regulatory Affairs to achieve company goals. Any other regulatory affairs tasks assigned or required as per the business needs...
As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect of the department and support interactions with global regulatory authorities. Senior Associate, Regulatory Affairs. Represent Regulatory Affairs on project teams and clos...
As an Associate Director of Regulatory Affairs, you will represent regulatory affairs on cross-functional teams and provide regulatory advice on clinical development matters. Associate Director, Regulatory Affairs. Regulatory Affairs, regulatory submissions, drug development, oncology, FDA, EMA. Fun...
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 ...
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...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
Director of Regulatory Affairs, you’ll take the helm of regulatory submissions and strategic planning for successful drug approvals across key markets, including the FDA, EMA, and other regulatory agencies worldwide. Are you ready to lead regulatory strategies that bring innovative therapeutics from...
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. ...