Regulatory Affairs Specialist — Submissions & Compliance

Medtronic plc; Taguig; On-site; PHP 450,000 - 750,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Flexible Benefits Package

Job summary

Medtronic plc in the Philippines is seeking an entry-level regulatory professional to coordinate and prepare document packages for regulatory submissions. You will lead materials for submissions, license renewals, and annual registrations, while ensuring labeling, manufacturing and clinical protocol changes comply with regulations.

As part of a specialist career stream, you will monitor regulatory procedures, interact with agencies as needed, and contribute to strategies for the earliest

Qualifications

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree and may require 0 years of experience for entry-level positions.

Responsibilities

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, 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.

Skills

Regulatory submissions

Documentation coordination

Regulatory compliance

Education

Baccalaureate degree

Job description

Medtronic plc in the Philippines is seeking an entry-level regulatory professional to coordinate and prepare document packages for regulatory submissions. You will lead materials for submissions, license renewals, and annual registrations, while ensuring labeling, manufacturing and clinical protocol changes comply with regulations.

As part of a specialist career stream, you will monitor regulatory procedures, interact with agencies as needed, and contribute to strategies for the earliest