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Regulatory Affairs Manager
NPAworldwide Recruitment Network
NPAworldwide Recruitment Network
 
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Job Location: Austin, TX
JOB DESCRIPTION

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

WHY IS THIS A GREAT OPPORTUNITY?

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

JOB DESCRIPTION

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.
QUALIFICATIONS

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

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




How to Apply:


 
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