Associate Regulatory Affairs Specialist

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

Job Description:

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• 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 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.

SPECIALIST CAREER STREAM: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.

DIFFERENTIATING FACTORS

Autonomy:Entry-level individual contributor on a project or work team.Works with close supervision.

Organizational Impact:Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity:Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.Makes minor changes in systems and processes to solve problems .

Communication and Influence:Communicates primarily with internal contacts within immediate group.Contacts others to gather, confirm and convey information.

Leadership and Talent Management:N / A – job at this level is focused on self-development .

Required Knowledge and Experience: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.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Requirements: