We are a small, private, medical device start-up company launching our first product. We are looking for a hands-on Quality Assurance and Regulatory Affairs Director who will responsible for all aspects of the quality and regulatory activities at the company. This person will be responsible for developing strategies for worldwide approval to introduce new and/or modified products to market. As the Management Representative, the Director has overall responsibility for the development, implementation ...
Our client is seeking a Medical Advisor II that will provide medical and scientific support to both internal team members and external healthcare decision makers and respond to information inquiries. The Medical Advisor will provide scientific support to the commercial activities, research, marketing, and report safety issues within the region consistent with legal and regulatory requirements.
•Develop and manage relationship with Thought Leaders through scientific exchange ...
Harvest Technical is seeking an Associate, Regulatory Affairs for our Biotech client in the Greater Bay Area.
The Associate, Regulatory Affairs is responsible for the coordination, preparation and submission of a variety of regulatory submissions including INDs, CTAs, BLAs and NDAs to regulatory authorities.
Attend project team meetings across functional areas
Prepare, submit, and maintain domestic and international regulatory filings, both ...
The Director of Regulatory will develop strategies for worldwide regulatory approval and introduction of the current generation and future generations of this clients medical device to market.
This position is responsible for, but not limited to, the following:
Develop a sense of regulatory leadership in the division on how the company will have a top notch regulatory system for the division’s development efforts.
Work with the clinical team to achieve regulatory approvals for ...
My name is Starr and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Fremont, CA. Details for the positions are as follows:
Prepares and submits product applications (510(k), BLA, PMA or their equivalent in foreign markets. Respond to deficiencies and/or questions related to regulatory submissions. Represents Regulatory Affairs on product ...
A highly reputable & distinguished corporation is currently looking for Regional Clinical Research Associates needed (location)
• Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (60% travel with 75% at peak times) for GCP compliance according to company SOPs and/or client guidelines
• Recruit investigators for participation in clinical trials
• Negotiate study budgets with investigators
• Obtain, review for appropriateness, and ...
My name is Jacqueline and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Associate for a prominent client of ours. This position is located in Santa Clara, CA. Details for the positions are as follows:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting ...
Represents Regulatory Affairs on product lifecycle teams by actively contributing to the development and implementation of regulatory strategies. Independently prepares and negotiates regulatory submissions for new products and product changes as required to ensure timely approval for market release. Performs tasks that support quality system compliance with US FDA Quality System Regulation and biologic regulations, other applicable international medical device regulations and ISO 13485. ...
Alliance BioPharm & Health Partners is seeking experienced Project Managers with background managing Pharmaceutical, Healthcare Implementation and Clinical Projects for Client Engagements.
In this role, you will work with respected pharmaceutical, healthcare, clinical research companies where you will you will be responsible for the delivery of a wide variety of projects.
Bio-Pharmaceutical Project Manager: Provides process and operational leadership to create and optimize project plans, ...
May 29 -
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