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Thepharmadaily

Regulatory Affairs specialist

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  • a month ago
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Job Description

At Medtronic, embark on a career of continuous exploration and innovation, championing healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a connected, compassionate world.
A Day in the Life
Responsibilities:
  • Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
  • Compile all necessary materials for submissions, license renewals, and annual registrations.
  • Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
  • Monitor and improve tracking and control systems.
  • Stay informed about regulatory procedures and changes.
  • Interact with regulatory agencies on defined matters.
  • Recommend strategies for the earliest possible approvals of clinical trials applications.
Specialist Career Stream:
  • Individual contributor with responsibility in a professional discipline or specialty.
  • Manage and deliver projects, working with other stakeholders to achieve desired results.
  • Mentor colleagues or direct the work of lower-level professionals.
  • Focus on delivering and overseeing projects from design to implementation, adhering to policies, and using specialized knowledge and skills.
Differentiating Factors:
Autonomy:
  • Productive individual contributor working independently with general supervision on moderately complex projects/assignments.
Organizational Impact:
  • Set objectives for own job area to meet project and assignment goals.
  • Contribute to project milestones and may be involved in cross-functional assignments.
Innovation and Complexity:
  • Address general problems that may require understanding of broader issues or other job areas.
  • Recommend enhancements in systems and processes to solve problems or improve job area effectiveness.
Communication and Influence:
  • Communicate primarily with internal contacts.
  • External interactions are less complex and problem-solving in nature.
  • Share information, status, needs, and issues to inform, gain input, and support decision-making.
Leadership and Talent Management:
  • Provide guidance and assistance to entry-level professionals and support career stream employees.
Required Knowledge and Experience:
  • Practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience.
  • Baccalaureate degree (or equivalent for degrees earned outside the U.S. per 8 C.F.R. 214.2(h)(4)(iii)(A)) and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.

More Info

Industry:Other

Job Type:Permanent Job

Date Posted: 09/10/2024

Job ID: 95722433

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