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regulatory affairs in San Francisco Bay Area

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  1. Director, Quality Assurance and Regulatory Affairs

    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 ...

  2. Medical Advisor (Nationwide)

    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.   Responsibilities: •Develop and manage relationship with Thought Leaders through scientific exchange ...

  3. Regulatory Affairs Associate

    Harvest Technical is seeking an Associate, Regulatory Affairs  for our Biotech client in the Greater Bay Area. Description:        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. RESPONSIBILITIES Attend project team meetings across functional areas Prepare, submit, and maintain domestic and international regulatory filings, both ...

  4. Director of Quality Assurance

      Our Client’s Quality Assurance and Consumer Protection Department has an opening for a Director of Quality Assurance. This position is located in the East Bay Area Position Purpose: The primary purpose of the position is to direct the Consumer Brands Quality Assurance function to meet the needs of our customers. This position reports to the Group Director Quality Assurance for Manufactured Products. Key Responsibilities include, but are not limited to: -Ensure co-packer plants and products meet ...

  5. Director of Regulatory Affairs

    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. Responsibilities: 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 ...

  6. Sr. Legal Assistant

    Empowering healthcare starts with you. At McKesson, whether you work in HR or marketing, finance or public affairs, you're making a difference. You'll spark a chain reaction that results in millions of people getting more from their healthcare. As the nation's leading healthcare services company, we touch virtually every aspect of healthcare. We empower our customers by delivering vital supplies and solutions. And we empower our employees through a supportive environment where opportunity and ...

  7. Regulatory Affairs Specialist

    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:   Job Description:   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 ...

  8. ~~Regional Clinical Research Associates needed (West Coast)

    Job Description A highly reputable & distinguished corporation is currently looking for Regional Clinical Research Associates needed (location) Job Description • 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 ...

  9. Regulatory Affairs Specialist - 53393

    Salary: Commensurate with experience Length: 11 Months Premium Healthcare Staffing Solutions LLC. is recruiting for a Regulatory Affairs Specialist. The candidate ensures  compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.         Researches medical literature, regulatory documents and related information for inclusion into clinical articles and regulatory submissions and for evaluating manuscripts for accuracy, completeness, and adherence to ...

  10. Regulatory Affairs Associate

        Hello,   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:   Job Description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting ...

  11. Agile PLM Systems Analyst

    Position Details: Job Title: Agile PLM Systems Analyst Location: Alameda, CA 94502 Duration: 3-6+ months (Strong possibility for extension) Job Description / Requirement: Primary Job Function • Defines, plans & designs client area application systems requirements for new or modified applications, in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions. • Specifically, has comprehensive knowledge ...

  12. Regulatory Affairs Specialist-33016

    Description: 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. ...

  13. Associate Director Quality Systems and Standards

    This position will provide technical leadership and strategy for all aspects of quality systems and standards of the business. Areas of responsibilities may include but not limited to regulatory intelligence, change control, complaints, metrics and reporting, quality system standards, policies and procedures, compliance readiness, regulatory interface, documentation and control systems and other duties as assigned   Responsibilities: Direct, provide oversight and input into the relevant quality ...

  14. Project Managers Bio-Pharm Exp

    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, ...