Back to Home Page
Communities Industries Employers JobSeekers Advertisers PJScout Resources Recruiters About
Keywords (e.g. nurse, sales) Category State City Radius
Regulatory Affairs Manager
NPAworldwide Recruitment Network
NPAworldwide Recruitment Network
How to Apply:

Job Location: Austin, TX

Job #: 28894
Title: Regulatory Affairs Manager
Job Location: Austin, Texas - United States
Employment Type:
Salary: $100,000.00 - $110,000.00 - US Dollars - Yearly
Other Compensation: 10% bonus, solid benefits plan
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes


Autstin based biotech - people are great - very strong benefits package - 20 days of PTO - will get lots of exposure to leadership in this role


The Manager, Regulatory Affairs will be responsible for:

  • Relating to premarket device licensing applications and postmarket activities including compliance activities for COMPANY products (review and approval of marketing materials and complaint, recall and MDR evaluations).
  • Liaison with scientific reviewers at worldwide regulatory agencies (e.g. FDA, Health Canada, EU Representative).
  • Submission management activities at all stages of development and postmarket, including quality system audits, recalls and medical device reports.

Key Responsibilities & Duties:

  • Responsible for compliance activities relating to MDRs (medical device reports) and product recalls, quality system audits and training as required
  • Prepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agencies (e.g. FDA, Health Canada, EU)
  • Review and approve validation protocols and product labeling (including advertising materials and website) and participation in design reviews to ensure adherence to regulatory requirements
  • Provide regulatory guidance to product core teams developing new products
  • Manages RA Associates
  • Acts as company representative with FDA, European Authorized Representative and other regulatory agencies to obtain approvals
  • Interface with regulators through the submission process, through industry associations and other forums to ensure corporate awareness of critical path requirements
  • Regulatory review of post-market product changes and decision on appropriate mechanism for change control (e.g. internal documentation, notification of change, supplemental submission)
  • Develop regulatory plans including rationale and internal documentation for non-filing decisions
  • Other duties as assigned.

Education and Experience:

  • Minimum B.Sc with at least 5 years of experience in Regulatory Affairs or a closely related discipline or
    Advanced degree in Molecular Biology or a related discipline is preferred (e.g. MSc. Candidate with 3-5 years` experience; OR PhD candidate with 2-4 years` experience)
  • Experience in a GMP regulated environment, medical device industry or equivalent
  • Experience working independently in a fast-paced environment with rapidly changing priorities
  • Experience managing multiple projects and people who may not be your direct reports

Training, Skills and Certifications/Licenses:

  • Able to interpret regulations / guidelines / standards and make appropriate judgments on what requirements are applicable to COMPANY products and what source data / documents demonstrate that COMPANY meets these essential requirements
  • Thorough knowledge of cGMP regulations and ISO 13485 standard for quality management systems
  • Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Ability to effectively contribute to and lead cross-functional project teams
  • Strong written and oral communication skills
  • Highly organized and detail oriented with exceptional proven time management and prioritization skills
  • Results and goal oriented
  • Ability to work independently and with minimal supervision in a fast paced and dynamic environment
  • Ability to handle the pressure of meeting tight deadlines
  • Fluency in additional languages not a requirement, but considered to be an asset

University - Bachelor`s Degree/3-4 Year Degree

How to Apply:

See all jobs in Austin TX
  Share this job
Share |

PJ Scout
Create Free Account

PJ Scout
    Electronic Recruitment since 1988. Copyright 1995-2020 NationJob, Inc. All rights reserved.
JobboardFinder - Search the best job board worldwide