Principal Regulatory Affairs Specialist

Mounds View, Minnesota
December 23, 2024
$55 / hour
Contract
Apply Now

Job Description

Job Summary:

  • Typically an individual contributor with responsibility in a professional discipline or specialty.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or may direct the work of other lower level professionals.
  • The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Responsibilities:

  • EU MDR Technical Documentation completion in addition to supporting responding to Notified Body questions (Working with a cross functional team).
  • Supporting implementation of MDR CE Marked products.
  • Drafting 510(k)s to be submitted to FDA regarding changes driven by MDR.
  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

DIFFERENTIATING FACTORS:

Autonomy:

  • Recognized expert, managing large projects or processes.
  • Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
  • Coaches, reviews and delegates work to lower level specialists.

Organizational Impact:

  • Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
  • May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity:

  • Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.
  • Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
  • Implements solutions to problems.

Communication and Influence:

  • Represents organization as a primary contact for specific projects and initiatives.
  • Communicates with internal and external customers and vendors at various levels.
  • May negotiate with others to reach understanding or agreement, and influence decision making.

Leadership and Talent Management:

  • Typically provides guidance, coaching and training to other employees within job area.
  • Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience:

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
  • May have broad knowledge of project management.
  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Related Jobs