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  • Job reference: RMS0203778

Regulatory Affairs Specialist

  • Sector: Healthcare & Medical
  • Location: Saudi Arabia
  • Job type: Contract
  • Date posted: 13/12/2018
  • Duration: 12 months
  • Time left:
    d h m s
    (24/01/19)
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The Role:
The Regulatory Affairs Specialist - Region may be involved in Pre or Postmarket duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure the healthcare business establishes and implements best practice processes and procedures in premarket and postmarket support. He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country.

Key responsibilities/essential functions include:
* File and maintain regulatory deliverables;
* Analyse and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies;
* Support regulatory inspections as required; and
* Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes.

Premarket
* Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions;
* Communicate with Product RA to establish regulatory requirements, including clinical trial data;
* Complete specific country testing and work with Product RA; arrange for test devices and support as needed;
* Provide RA oversight to clinical studies to ensure regulatory requirements are met;
* Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required;
* Act as liaison with external regulatory reviewers to gain rapid approval of submissions; and
* Work with Product RA and Pre Market CoE for countries with license expiration requirements establish plan and deliverables for timely submission for renewal of license.

Postmarket
* Monitor external information for incidents or issues that may involve the business products communicate information internally in a timely manner;
 Liaise with relevant personnel to ensure appropriate, timely input is provided for postmarket reports;
* Review field action information to determine if reportable in local country; and
 Liaise with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.

Required Qualifications:
1. Bachelor's Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 1 year progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations;
2. Strong analytical skills;
3. Ability to work in a team environment with minimal supervision on projects and activities;
4. Ability to prioritize, plan & evaluate deliverables;
5. Knowledge and experience conducting scientific, regulatory, legal, or business research;
6. Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner;
7. Experience using spreadsheet and presentation software; and
8. Knowledge of Arabic language.

The Company:
Global healthcare company based in Riyadh, Saudi Arabia

About Fircroft:
Fircroft has been placing people in specialist technical industries for approaching half a century, focusing on mid to senior level engineers for contract and permanent roles worldwide. By applying for this job you give consent for Fircroft to contact you, via email & telephone, to discuss your application along with future positions and Fircroft's services.

Fircroft is registered as a Data Controller with the Information Commissioner as required under the General Data Protection Regulation 2016/679. Fircroft will only process your personal data for the specific purposes of managing your application.

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