Regulatory Affairs Manager Middle East

  • Listed: July 21, 2016 7:47 pm
  • Expires: This ad has expired
  • Company Name: TEC Group
  • Job Type: Others
  • Salary Package: Negotiable
  • Required Experience: 5-10 Years
  • Minimum Education: Anything
  • Emirates: Dubai
  • Country: United Arab Emirates
  • Employer Email: http://www.tecgroup.net

Description

Full-time, Permanent
Regulatory Affairs Manager

Client Description:

An international medical device company

Role:

Regulatory Affairs Manager

Term Status/Duration:

Permanent

Location:

UAE, Dubai

Rate/Salary:

Negotiable

Job Description

As a Regulatory Affairs Manager you will be responsible for coordinating and preparing document packages for regulatory submissions from all areas of company, internal audits and inspections. You will be compiling all materials required in submissions, license renewals and annual registrations. One of the key focuses of the role will be recommending changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Our Regulatory Affairs Manager will be also monitoring and improving tracking/control systems as well as keeping abreast of regulatory procedures and changes. You will have direct interaction with regulatory agencies on defined matters.

Responsibilities:
To manage the regulatory department and develop processes so that all regulatory action / product registration etc. are done in a timely fashion and in compliance with the local and company requirements
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Guiding, directing and motivating subordinates – providing guidance and direction to subordinates, including setting performance standards and monitoring performance
Interpret regulatory and quality rules or rule changes and ensure that they are reported to management and captured through corporate policies and procedures
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
Recommend changes to company procedures in response to changes in regulations or standards
Obtain and report updated information regarding domestic or international laws, guidelines, or standards
Support regulatory activities with Business Units (BU’s)
Interface with the local competent authorities
Ensure regulatory and quality compliance to local country regulations as well as company requirements
Maintain up-to-date knowledge of Medical Devices Regulations and Guidelines for licensing of products for the countries responsible for
Define the regulatory licensing strategy and identify required elements for each submission
Ensure proper elements of product submissions are collected from BU’s, prepared, and submitted in a timely manner
Ensure full execution of FA recall based on the company plan and country regulation
Qualifications required:
At least 7 years of experience in Regulatory Affairs management
Experience in working in multinational companies (medical devices or pharma preferred)
Fluent English
Strong negotiation skills
Applying for the job

There are various ways to apply for this position:
Apply direct from the website (www.tecgroup.net) by clicking “apply now”
Contact the consultant directly:
Amira Chelghoum –

Mention that you found this ad on Bibango.com when you Call or Message.

Share with friends
Listing ID: 1385790cfcc4a026

Report problem

Processing your request, Please wait....