Regulatory Affairs Associate — Submissions & Compliance

Medtronic plc; Taguig; On-site; PHP 400,000 - 640,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Medtronic Incentive Plan (MIP)

Job summary

Medtronic plc in the Philippines seeks an entry-level Specialist to support regulatory submissions across the company, coordinate document packages, and prepare materials for license renewals and registrations.

You will monitor procedures, suggest labeling and protocol improvements for compliance, interact with regulators as needed, and contribute to strategies for timely approvals of clinical trial applications.

Qualifications

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A).)
• 0 years of experience required.

Responsibilities

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits and inspections.
• 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.

Education

Baccalaureate degree

Job description

Medtronic plc in the Philippines seeks an entry-level Specialist to support regulatory submissions across the company, coordinate document packages, and prepare materials for license renewals and registrations.

You will monitor procedures, suggest labeling and protocol improvements for compliance, interact with regulators as needed, and contribute to strategies for timely approvals of clinical trial applications.