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  • Senior Regulatory Affairs Specialist Riyadh Saudi Arabia
  • Teleflex in Riyadh Saudi Arabia, , Saudi Arabia
  • jobs
  • 1 week ago

jobs description

Expected travel: Up to 10%

About Teleflex

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Position Summary

The Senior Regulatory Affairs Specialist will develop strategies for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction for the Middle East and North Africa (MENA... region. The role will be based in Saudi, with a 50% focus on Saudi and 50% focus on the wider MENA region.

KEY RESPONSIBILITIES:
• Responsible for ensuring the implementation of regulatory compliance as required by international and local regulations and Teleflex policies and procedures.
• Responsible for supporting and maintaining regulatory approval of all Teleflex products intended for distribution in the MENA region.
• Support and execute on strategies to comply with regulations in order to achieve early market entry and cost-effective operation of the business while maintaining regulatory compliance.
• Create and manage country specific technical documentation required to support registration in the MENA region.
• Submit documentation for registration and reregistration with distributor countries in the MENA region.
• Support discussions with authorities to better understand regulations, build relationship and clarify issues.
• Assess product changes, to ensure compliance with regulatory requirements.
• Review and assess change control activities for potential impact on current regulatory filings in the MENA region
• Manage and respond to regulatory impact assessments in a timely manner.
• Monitor and assess local regulations for impact and implement changes as required to ensure compliance at all times is maintained.
• Maintenance of regulatory procedures to ensure continued compliance.
• Ensure continual quality system compliance by adherence to established and evolving internal requirements.
• Serves as RA team member for promotional materials review and product labelling as they relate to registration and commercialization of medical devices in the MENA region.
• Work with Quality, Operations, Engineering to support complex registrations and recommend solutions to address potential regulatory issues.
• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks
• Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
• Assist in mentoring and development of staff members as part of the role.
• Provide support during audits/inspections, as necessary.
• Apply technical solutions to problem solving.
• Apply technical solutions to quality improvement projects.
• Use technical writing skills to clearly describe technical information.

ESSENTIAL SKILLS / EXPERIENCE
• Engineering/Science qualification with 5 years of working within R&D/QA/RA in a medical device environment
• Minimum of 3 years' experience in R&D, QA/RA, Validations
• Fluent in both Arabic and English, both written and oral
• Ability to work well under deadlines and pressure
• Excellent technical writing experience within a medical device environment
• Attention to detail and accuracy
• 3/4 years' experience in Risk, Clinical and Biocompatibility – an advantage
• Problem solving skills for developing creative solutions and meeting objectives are required
• Skills that enable coordination of data, including MS-Office (PowerPoint, Word, MD Project, Outlook and Excel)
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management

BEHAVIORS / VALUES:
• Approachable and enthusiastic
• Flexible and adaptable
• Able to work on own initiative and as a team player
• Good organizational skills with cultural awareness and sensitivity
• Good judgment and problem-solving ability and can understand the impact of decision making on both Teleflex Medical and their customers
• Apply Teleflex’s Core Values

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time. Teleflex is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries
Riyadh Saudi Arabia

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