Regulatory Affairs Manager

Abbott; Dubai; On-site; AED 293,000 - 368,000; Full time

Job summary

A global healthcare firm in Dubai is seeking a Regulatory Affairs Manager to coordinate regional regulatory activities for their Infectious Disease portfolio. The ideal candidate will have at least 8 years of experience in Regulatory Affairs with a solid understanding of medical device regulatory frameworks and excellent communication skills in English and Arabic. This role involves managing the regulatory submissions and serving as the regulatory liaison during product life cycles, and offers opportunities for professional growth within a supportive international company environment.

Benefits

International career development opportunities

Employee engagement initiatives

Diversity and inclusion programs

Qualifications

• Minimum 8 years of experience in Regulatory Affairs in Medical Devices/IVDs.
• Understanding of the medical device regulatory and IVD frameworks.
• Good knowledge of the regional regulatory landscape.

Responsibilities

• Coordinate and manage Regional Regulatory activities for the Infectious Disease portfolio.
• Ensure the preparation and timely completion of submissions for in vitro diagnostic devices.
• Serve as the regulatory liaison throughout the product lifecycle.

Skills

Regulatory strategy execution

Project management

Interpersonal skills

Communication skills in English and Arabic

Education

Bachelor's or Master's degree in a related field

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

Overview

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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 youll tackle a wide array of problems including some of the worlds greatest healthcare challenges while experiencing a myriad of cultures geographies and technologies.

As Regulatory Affairs Manager youll 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 Youll 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 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.
• Provide 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.
• Serve as the regulatory Liaison through the life cycle.
• Participate in the required following: product plan development and implementation regulatory strategy risk management commercial strategies.
• Serve as regulatory representative to marketing research teams and regulatory agencies.
• Advise development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations.

Product Registrations

• Ensure 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 Manufacturers 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

• Bachelors/masters 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.

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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

Required Experience:

Manager

IsExpired: false