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Specialist Regulatory Affairs

1.00 to 10.00 Years   Pakistan   07 Apr, 2023
Abbott
1 Jobs Openings
Job LocationPakistan
EducationNot Mentioned
SalaryNot Mentioned
IndustryOther Business Support Services
Functional AreaNot Mentioned

Job Description

JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.OverviewFor the Abbott Rapid Diagnostics Infectious Disease - Emerging Markets Business Unit, we are looking for a talented and dynamic Senior Regulatory Specialist to coordinate and manage the Regulatory activities related to the Abbott portfolio in Pakistan and a designated list of SAARC countries.Responsibilities

  • Support and develop regulatory submission plan for Pakistan and designated list of SAARC countries in collaboration with project team, manufacturing sites, supply chain, marketing and country manager.
  • Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates
  • Ensure timely execution of regulatory strategies as per plan
  • Track regulatory milestones in internal Regulatory database;
  • Report submission status via defined Key Performance Indicators;
  • Represents RA function at relevant meetings;
  • Responsible for review and facilitating local HA approval ˙of promotional material as required by local regulation
  • Responsible for post market surveillance activities in countries of responsibility
  • Support Abbott strategic Quality and Regulatory Affairs Goals and objectives.
  • Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders.
Qualifications
  • BSc or equivalent.
  • A minimum of 5 years? experience in Regulatory Affairs in Medical Devices, ideally in IVDs
Competencies and Attributes
  • Demonstrable working knowledge of the medical diagnostics industry
  • Demonstrated capacity in project management
  • Able to navigate in a cross functional environment
  • Strong Knowledge of the Medical Device regulations and regulatory framework of Pakistan and SAARC countries
  • Excellent written and oral communication skills in English
  • Attention to detail.
  • Strong interpersonal skills.
  • Highest levels of integrity and diplomacy.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
Connect with us at www.abbott.com, on at www.linkedin.com/company/abbott-/ , on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews.The salary for this role is between:N/A˙ ˙ ˙JOB FAMILY:Regulatory OperationsDIVISION:IDEM ARDx Infectious Disease Emerging MarketsLOCATION:Pakistan > Islamabad : Plot No. 136, Street No. 9, I 10/3, Industrial AreaADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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