Job Description

JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of .
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Regulatory Affairs Manager
This position works out of our UAE location in the Abbott Rapid Diagnostics Division
About Abbott Rapid Diagnostics Division
We are the world leader in Rapid Diagnostics at the point of care. Working with us, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges, while experiencing a myriad of cultures, geographies,
and technologies.
As Regulatory Affairs Manager, you'll be responsible to coordinate and manage the Regional Regulatory activities for the Infectious Disease portfolio as well assist with specific regional regulatory tasks as required.
This includes defining, implementing and managing RA processes to support business objectives on a continual improvement basis over their lifetime. The objective of this role is to ensure that product registrations are acquired and or alternative pathways are in place to ensure compliant import of product to the countries` strategies for product launches and:
-Assist with prioritization and compliance relating to meeting regulatory requirements consistently
-Work with business units to understand business needs pertaining to regulatory requirements in countries under commercial responsibility and help with articulation and definition of requirements as needed.
-Leads/supervises a team of 2 professionals within the Regulatory Affairs Sub-Function.
First level manager of a work team that may comprise professionals, technical and/or administrative staff.
Typically without budget or hire/fire authority.
Focuses on supporting compiling regional registration dossiers for submission, mentoring, coaching, and coordination.
What You'll do-
As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Regulatory Strategies:

• Support in the Preparation of product registration plans in accordance with business strategies of for review and approval by the Regulatory Affairs Director EMEA.

• Collaborate with Abbott Global Regulatory teams and Abbott Legal Manufacturer RA counterparts to be informed on, and understand, high-level regulatory strategies and key certification approval timelines for new products.

• Provides input to product-launch core teams with regards to Regional Regulatory strategies for product launches, and new market expansion projects.

• Interact with the regulatory agencies to expedite registration approvals.

• Serves as the regulatory Liaison through the life cycle.

• Participates in some/the required following: product plan development and implementation, regulatory strategy, risk management, commercial strategies.

• Serves as regulatory representative to marketing, research teams and regulatory agencies.

• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Product Registrations

• Ensures the preparation and timely completion of submission of registrations for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs for ARDX division for the region under responsibility.

• Participation on cross functional project teams to provide input that enables strategic guidance to meet the regional regulatory requirements for new product introductions.

• Conduct regulatory impact assessments for new product introductions and assist in the development of registration plans.

• Conduct Assessments and applicable documentation of changes in product, IVDR changes, manufacturing processes, labelling affecting IVD products distributed in the region under responsibility

• Work closely with commercial regional teams under responsibility and align on business requirements and objectives

• Ensures efficient review of advertising and promotional material and/or publicly disseminated information for compliance with local country specific requirements.

• Oversee that all regulatory matters are to ensure compliance of registrations held under the related Abbott entities and the distributors.

• Working with the Authorities and Authorized Representatives to ensure resolve on any queries arising from registrations, event reporting, post market surveillance, promotional material review and trademark applications.

• Supports the Legal manufacturer in the reporting of complaints, adverse events and FSCA/FSN notifications to the Regulatory Authorities in the respective countries as applicable to regulations.

• Keep abreast of changes in regulation and develop strategies for compliance whilst minimizing impact to business.

Regulatory Intelligence:

• Oversees the gathering and collation of regulatory intelligence (new implementation or changing of medical device & IVD regulations) in the defined region and coordinates the dissemination of its impact to internal stakeholders (mainly Liaises the Legal Manufacturer's RA counterparts, Regulatory Intelligence team, Government Affairs & the Regional commercial team)

• Oversee that RIGOUR is updated and contents verified for the region

• Builds strong connections with external partner network within government authorities, Industry associations and business partners in the region.

• Implement and maintains an efficient process for product changes, compiling impact assessment in the region and communicates changes to relevant stakeholders as required

• Promote awareness of regulatory and customer requirements throughout the organization

Quality

• Perform regulatory audits of distributors in the assigned region, as needed.
• Support the maintenance of the Quality Management System & implement improvements when required.

Required Qualifications
Bachelor's/master's degree /engineering, ( 13 years)
Medical/Biomedical/pharmaceutical background or other science related field
Experience
Minimum 8 years

• Understanding of medical device regulatory and IVD frameworks.

• Track record of successful execution of Regulatory strategy to meet business needs.

• Good knowledge of the regional regulatory landscape and policies across.

• Demonstrated capacity in project management.

• 8-13+ years of experience in Regulatory Affairs in Medical Devices/IVDs.

• Able to navigate in a cross functional environment

• Ability to anticipate risks and develop mitigation plan

• Solution oriented, organized with good attention to details

• Excellent written and oral communication skills in English, Arabic (French, Spanish other language are plus)

• Strong interpersonal skills.

• Highest levels of integrity and diplomacy.

• Capacity to maintain the highest levels of confidentiality internally and externally

• People management skills

• Ability to lead meetings (by phone, video conference and face to face) to drive results and build relationships

• Working in a small team developing an environment of trust and effective teamwork is essential

• Microsoft Excel / Word / PowerPoint Software

• Effective presentation skills

• Basic Computer Skills

• Understanding of medical/technical nature of the African regulatory IVD environment and its impact

• Thorough knowledge of Quality management systems and principles pertaining to medical products

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews.
The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Regulatory Operations
DIVISION: ID Infectious Disease
LOCATION: United Arab Emirates
Dubai : Ubora Tower2
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Not specified
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Not Applicable

Skills Required