Regulatory Affairs Analyst (Fort Defiance)

Caris Life Sciences in Fort Defiance, AZ

  • Industry: Advertising/Marketing/Public Relations - Marketer/Market Researcher/Data Analyst
  • Type: Full Time
  • $102,495.00 - 102,880.00
position filled

Description

Position Summary:

The Regulatory Affairs Analyst is responsible for maintaining regulatory compliance to all applicable regulatory requirements.

Job Responsibilities:

The Regulatory Affairs Specialist will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

Requirements:

  • Knowledge, Skills and Experience Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier and Technical File. Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products. Identify requirements and potential obstacles for new product development teams. Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance. Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities. Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Author and update SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review. Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance. Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Review of advertising and promotional items. Assist in SOP development and review.
  • Education, Certification, Licensure, and/or Experience A Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. A minimum of 5 years of experience in an FDA regulated industry. A minimum of 3 years of Regulatory Affairs experience. Regulatory Experience required (e.g., 21 CFR Part 820, ISO 13485, MDSAP). RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Qualifications

    You may be interested in these similar jobs!
    Obstetrics/Labor and Delivery Registered Nurse
    The Gypsy Nurse in Fort Defiance, AZ

    Obstetrics/Labor and Delivery RN ? Fort Defiance, AZ Fort Defiance was established in 1851 and is part of the land that is considered sacred to the N…

    Read More
    Coding Analyst/Education Specialist (Fort Defiance)
    Juju in Fort Defiance, AZ

    Job Summary The Coding Analyst/Education Specialist supports the vision of the Total Healing Environment and the values of respect, integrity, accoun…

    Read More
    Travel RN - PACU in Fort Defiance, AZ
    Nurses PRN in Fort Defiance, AZ

    This is a travel nursing or contract position for a registered nurse in Fort Defiance, Arizona in the ARIZONA area. It is a great opportunity for tra…

    Read More
    Travel RN - L&D in Fort Defiance, AZ
    Nurses PRN in Fort Defiance, AZ

    We are looking for a registered nurse to fill a travel nursing or contract job in Fort Defiance, Arizona in the ARIZONA area. It is a great option fo…

    Read More
    MedSurg RN Assignment: Fort Defiance, Arizona
    Travel Nurse Across America in Fort Defiance, AZ

    Travel Nurse across America is seeking a qualified Medical-surgical RN needed for travel nurse assignment in Fort Defiance, AZ. This assignment is in…

    Read More
    Pediatric Nurse
    American Mobile in Fort Defiance, AZ

    Duration: 13 Weeks Start Date: February 07, 2020 Organization: American Mobile Healthcare Employment Type: Temporary Weekly Pay: Call for de…

    Read More
    Travel Operating Room Nurse (OR RN), Fort Defiance, AZ
    Triage Staffing - 4.9 Google Rating in Fort Defiance, AZ

    HIGH PAYING POSITION Travel Operating Room Nurse (OR RN) Fort Defiance, AZLocation:?????????Fort Defiance, AZStart Date:???????2/17/2020Shift Details…

    Read More
    L&D
    Assured Nursing in Fort Defiance, AZ

    Job Specifics Location: Fort Defiance, AZ 86504 Shift: 8:00am-5:00pm License: RN Start Date: January 14, 2020 End Date: January 21, 202…

    Read More
    Emergency Room RN
    Soliant Health in Fort Defiance, AZ

    Emergency Room Registered Nurse - Fort Defiance, ArizonaSoliant is looking for an experienced Nurse to fill an ER Travel role in Fort Defiance, AZ. T…

    Read More
    Now Accepting Resumes (Fort Defiance)
    Naumann Hobbs Material Handling in Fort Defiance, AZ

    Please submit resume for consideration for open employment

    Read More