Core Diagnostics Regulatory Affairs Managers

     

JOB DESCRIPTION:

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

License/Certification

Language Proficiency

English Fluent

     

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:

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)