Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc. Previous APAC regulatory experience in the medical device or pharmaceutical industries. ...
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 ...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. As a key player in regulatory oversight, you will help ensure product compliance with global regulatory standards, including ISO 13485 and FDA regulations. ...
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 Senior Regulatory Affairs Specialist plays a vital role in ensuring compliance with global regulatory standards for medical devices. The ideal candidate will possess strong regulatory expertise, with a focus on technical documentation and regulatory compliance. This role involves managing regula...
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...
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...
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:. ...
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...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...
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...
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...
Associate Director Regulatory Affairs (Temp to Perm). Oversee regulatory submissions and approvals, ensuring alignment with global regulatory standards. Lead regulatory strategy development and execution for both U. Collaborate with stakeholders to establish project timelines and regulatory goals. ...
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. The...
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...
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 ...
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...
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. ...
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...
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...
They are seeking a Program Manager to lead and manage a team of engineers to support a water utility generator upgrade program. We are currently looking to hire a Program Manager – Engineering for our client based in California, this is a hybrid role that will also include travel to project sites. T...
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...
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...
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...