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 ...
Senior/Principal Regulatory Specialist (Hybrid). Lead regulatory strategy and submissions (PMA, IDE) for Class III medical devices. Support global regulatory registrations and maintain compliance. ...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
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...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. This role will involve collaborating with cross-functional teams, contrib...
As a Compliance Specialist, you will ensure regulatory compliance with federal, state, and local laws governing the production, distribution, and sale of alcoholic beverages. We are seeking a Compliance Specialist to join our growing team. Prepare for and assist with regulatory audits and inspection...
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. ...
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 (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. Serve as the Global Regulatory Lead on project teams and key sub-teams. Develop and implement competit...
They are looking for a Director of Regulatory Affairs with experience to spearhead regulatory strategies for Class II and Class III Cardiology and/or Cardiovascular Devices. If you would like to learn more about this Director of Regulatory Affairs opportunity and have the desire to build and develop...
Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. The position is responsible for providing...
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...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
As the Regulatory Affairs Director, you will have the opportunity to lead Allogeneic trials – the most innovative in history! This role allows you to bring past Regulatory knowledge to the table, while also be creative in strategic discussions and decisions. Regulatory Affairs experience within a ph...
Compliance & Ethics Specialist. Perform field and desk monitoring to ensure compliance with to relevant laws and regulations. Track, analyze, and report on compliance monitoring progress, identifying trends and potential risks. Provide compliance guidance and support for various initiatives and proj...
A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs. Associate) Director, Regulatory Aff...
My client is seeking a Director, Regulatory Affairs to join their Regulatory team. At least 8-10+ years of Regulatory Affairs experience. Be able to prepare nd lead successful regulatory meetings and major health authority interactions. Extensive global regulatory submission experience (IND/CTA/BLA/...
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...
Manage projects during production to ensure the projects are completed within budget. Multifmaily Project Engineer/Assistant PM. Offering ESOP, competative salary, excellent benefits for this Multifamily Project Engineer. Job duties of a Project Engineer:. ...
We are hiring a Senior Compliance Analyst (Privacy) to join our team!. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compliance management. Develops and maintains the FWA risk assessment plan, in close collaborati...
As a Project Manager, you will lead commissioning projects, develop strategic client relationships, and perform Commissioning Authority (CxA) duties while building your team. Project Manager - Commissioning Authority. Oscar's client is seeking an experienced CxA Project Manager to join their growing...
Senior Quality Assurance Specialist – Southern California, $90K-$100K. I’m currently partnered with an innovator in connectivity solutions, who are looking for a Senior Quality Assurance Specialist. In this role, you'll play a key part in ensuring compliance with ISO 9001 standards, collaborating ac...
SEEKING COMMERCIAL DRYWALL PROJECT MANAGERS & ESTIMATORS. I am working with multiple well-respected, firmly established Commercial Drywall Contractors seeking experienced Project Managers and Estimators. Commercial Drywall Project Manager OR Estimator Experience Required. If you have the following, ...