Core Diagnostics Regulatory Affairs Managers

Abbott; Porto; Presencial; EUR 70 000 - 100 000; Tempo integral

Resumo da oferta

Abbott is seeking a Regulatory Affairs Manager in Porto, Portugal to lead regulatory strategy and cross-functional collaboration for product launches and lifecycle changes. You will drive regulatory submissions, maintain site compliance, and coordinate with R&D, Quality, Manufacturing, and other groups to ensure timely global market access.

Ideal candidates have 7+ years in Regulatory Affairs in healthcare, with strong knowledge of global regulatory requirements and quality systems, plus

Qualificações

• Bachelor's degree in a scientific, engineering, regulatory, or related field.
• Minimum 5 years in Regulatory Affairs with 7+ years in healthcare/regulatory environments.
• Experience supporting product launches and lifecycle management.
• Knowledge of global medical device regulatory requirements and quality systems.
• Strong project and stakeholder management; cross-functional collaboration.

Responsabilidades

• Serve as the primary Regulatory Affairs contact for the manufacturing site and leadership.
• Develop and execute regulatory strategies to support launches, including hardware, software, and changes.
• Assess regulatory impact of product, manufacturing, supplier, and process changes.
• Lead regulatory activities for lifecycle management: registrations, submissions, amendments.
• Collaborate with R&D, Quality, Manufacturing, Operations, Supply Chain, Marketing, and Commercial teams to ensure regulatory requirements.
• Coordinate with stakeholders to obtain documentation, testing data, certifications, and deliverables.
• Ensure ongoing compliance of products and site operations with regulatory requirements and commitments.
• Support development and improvement of procedures to maintain site regulatory compliance.
• Monitor regulatory trends and drive actions; manage multiple projects with timelines.

Conhecimentos

Regulatory Strategy

Cross-functional Leadership

Global Regulatory Knowledge

Lifecycle Management

Documentation & Submissions

Formação académica

Bachelor's degree

Descrição da oferta de emprego

Regulatory Affairs Manager

Location : Porto/Portugal

MAIN PURPOSE OF ROLE

Serves as the primary Regulatory Affairs representative for the manufacturing site, providing strategic and operational regulatory support to ensure successful product commercialization and ongoing regulatory compliance. Responsible for developing and executing regulatory strategies for new product launches, product changes, manufacturing changes, and lifecycle management activities. Partners with cross-functional teams to assess regulatory impact, obtain required regulatory deliverables, maintain product and site compliance, and ensure alignment with evolving global regulatory requirements. Participates as the regulatory representative in site management reviews and provides regulatory guidance to site leadership.

Main Responsibilities

• Serve as the primary Regulatory Affairs point of contact for the manufacturing site and provide regulatory guidance to site leadership and cross-functional stakeholders.
• Develop and execute regulatory strategies to support new product launches, including hardware, software, and product modifications, ensuring timely commercialization in global markets.
• Assess regulatory impact of product, manufacturing, supplier, process, labeling, and software changes and provide recommendations to support change implementation and market continuity.
• Lead regulatory activities associated with product lifecycle management, including registrations, submissions, notifications, amendments, and regulatory assessments required to maintain market access
• Collaborate with R&D, Quality, Manufacturing, Operations, Supply Chain, Marketing, and Commercial teams to ensure regulatory requirements are incorporated into business and product development activities.
• Coordinate with internal and external stakeholders to obtain technical documentation, testing data, certifications, and other regulatory deliverables required to support regulatory submissions and commercialization activities.
• Ensure ongoing compliance of products and site operations with applicable regulatory requirements, standards, registrations, and commitments.
• Support the development, implementation, and continuous improvement of procedures and controls necessary to maintain regulatory compliance at the site level.
• Monitor emerging regulations, standards, guidance documents, and industry trends; assess the impact on products, manufacturing operations, and quality systems; and drive implementation of required actions.
• Manage multiple regulatory projects simultaneously, establish priorities, identify risks, and ensure deliverables are completed within established timelines

Qualifications

Education

Education Level Major/Field of Study Or Education Level

Bachelors Degree (+/- 16 Years) X an equivalent combination of education and work experience

Experience/Background

Minimum 5 years Bachelor's degree in a scientific, engineering, regulatory, or related discipline.

7+ years of Regulatory Affairs experience in a regulated healthcare industry.

Demonstrated experience supporting product launches and lifecycle management activities.

Knowledge of global medical device regulatory requirements and quality system regulations.

Strong project management, stakeholder management, and organizational skills.

Ability to manage multiple priorities and work effectively in a cross-functional environment.

Strong written and verbal communication skills with the ability to influence and collaborate across functions.

Licenses and Certifications

Language Proficiency

English Fluent