Core Diagnostics Regulatory Affairs Managers

Abbott Laboratories; Porto; Presencial; EUR 70 000 - 95 000; Tempo integral

Resumo da oferta

Abbott Laboratories in Porto, Portugal seeks a senior Regulatory Affairs professional to lead regulatory strategy for new product launches, changes and lifecycle management at the manufacturing site. You will partner with R&D, Quality, Manufacturing and Supply Chain to ensure timely approvals and ongoing compliance across global markets.

The role requires building regulatory plans, coordinating submissions, and guiding cross-functional teams through complex regulatory requirements, while

Qualificações

• 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.
• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory affairs

Regulatory strategy

Project management

Cross-functional collaboration

Documentation

Communication skills

Formação académica

Bachelor's degree

Descrição da oferta de emprego

JOB DESCRIPTION:

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
• Education Level: Bachelors Degree (+/- 16 Years)

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

Job Family

Regulatory Operations

Division

CRLB Core Lab

LOCATION

Portugal > Porto : Rua Orlando Ribeiro, No. 78, Leça do Balio

ADDITIONAL LOCATIONS

Work SHIFT

Standard

Travel

Yes, 10 % of the Time

Medical Surveillance

Not Applicable

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Payment

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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