MEDTRONIC
At Medtronic, we value what makes you unique. Be part of a company
that thinks differently to solve problems, make progress and deliver
meaningful innovations
OUR PURPOSE
At our Regulatory Affairs department in Medtronic, plc, we focus on
harnessing our collective strength to deliver best-in-class solutions
that benefit patients and our cross functional partners. Senior
Regulatory Affairs Specialists are directly involved in regulatory
activities supporting the global commercialization and sustaining of
products on the market in compliance with all regulatory requirements.
Come for a job, stay for a career!
A DAY IN THE LIFE OF:
? Directs or performs coordination and preparation of document
packages for regulatory submissions.
? Teams with business unit Regulatory Affair Specialists and
international regulatory staffs to provide regulatory support for new
products/therapies and changes to existing products. Work with
engineers and technical experts to develop robust regulatory
strategies and resolve questions from regulatory agencies.
? Leads or compiles all materials required in submissions, license
renewal and annual registrations.
? Recommends changes for labeling, manufacturing, marketing, and
clinical protocol/evaluation reports for regulatory compliance.
? Keeps abreast of regulatory procedures and changes. Develop
internal procedures to ensure continuous compliance with all
regulatory requirements.
? May direct interaction with regulatory agencies on defined
matters.
? Support regulatory compliance activities, including manufacturing
site registration & GMP audits as needed.
? Identify and develop best practices within the Regulatory Affairs
department including continuous development initiatives (MOS/COS)
KEY SKILLS & EXPERIENCE
? Bachelors degree required
? Minimum of 4 years of relevant experience, or advanced degree with
a minimum of 2 years relevant experience
? Experience in Medical device or Pharma is essential
? Experience or working with regulatory files for USA / EU
? Lead projects/programs on own initiative and filed them
? Experience working directly with FDA, and notified bodies in the
Europe
? Experience working with Class III medical devices or DMS Drug
master file
? Experience filing using the ECTS system
? You are experienced with Microsoft applications including Word,
Excel, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data
Management Systems are desirable
Medtronic offer a competitive Salary and flexible Benefits Package Position: Senior Regulatory Affairs Specialist - Permanent
MEDTRONIC
At Medtronic, we value what makes you unique. Be part of a company
that thinks differently to solve problems, make progress and deliver
meaningful innovations
OUR PURPOSE
At our Regulatory Affairs department in Medtronic, plc, we focus on
harnessing our collective strength to deliver best-in-class solutions
that benefit patients and our cross functional partners. Senior
Regulatory Affairs Specialists are directly involved in regulatory
activities supporting the global commercialization and sustaining of
products on the market in compliance with all regulatory requirements.
Come for a job, stay for a career!
A DAY IN THE LIFE OF:
? Directs or performs coordination and preparation of document
packages for regulatory submissions.
? Teams with business unit Regulatory Affair Specialists and
international regulatory staffs to provide regulatory support for new
products/therapies and changes to existing products. Work with
engineers and technical experts to develop robust regulatory
strategies and resolve questions from regulatory agencies.
? Leads or compiles all materials required in submissions, license
renewal and annual registrations.
? Recommends changes for labeling, manufacturing, marketing, and
clinical protocol/evaluation reports for regulatory compliance.
? Keeps abreast of regulatory procedures and changes. Develop
internal procedures to ensure continuous compliance with all
regulatory requirements.
? May direct interaction with regulatory agencies on defined
matters.
? Support regulatory compliance activities, including manufacturing
site registration & GMP audits as needed.
? Identify and develop best practices within the Regulatory Affairs
department including continuous development initiatives (MOS/COS)
KEY SKILLS & EXPERIENCE
? Bachelors degree required
? Minimum of 4 years of relevant experience, or advanced degree with
a minimum of 2 years relevant experience
? Experience in Medical device or Pharma is essential
? Experience or working with regulatory files for USA / EU
? Lead projects/programs on own initiative and filed them
? Experience working directly with FDA, and notified bodies in the
Europe
? Experience working with Class III medical devices or DMS Drug
master file
? Experience filing using the ECTS system
? You are experienced with Microsoft applications including Word,
Excel, Sharepoint, Teams, and knowledge of Adobe Acrobat, Data
Management Systems are desirable
Medtronic offer a competitive Salary and flexible Benefits Package
We need : English (Good)
Type: Permanent
Payment:
Category: Others
