Senior Regulatory Strategy Lead - MedTech Global Access

Becton Dickinson; Limerick; On-site; EUR 57,000 - 86,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

BD (Becton, Dickinson and Company) in Limerick, Ireland, is seeking a Senior Regulatory Affairs Specialist to support the infusion preparation and delivery portfolio, ensuring regulatory compliance across the product lifecycle. You will work with Quality, R&D, Medical Affairs and Marketing to enable timely market access for innovative healthcare solutions.

You will interpret EU MDR, UK MDR and FDA requirements, prepare technical documentation, and contribute to continuous improvement of

Qualifications

• Regulatory experience within the medical device industry.
• Knowledge of medical device regulatory requirements, submissions, product registrations, technical documentation, and compliance activities.
• Understanding of EU MDR, UK MDR, FDA requirements and other international regulatory frameworks.

Responsibilities

• Provide regulatory guidance for product development, design changes, and change control activities throughout the product lifecycle.
• Review and approve technical and project documentation, including design verification reports, labeling, and regulatory submissions.
• Support product launches by developing regulatory strategies for timely market access and commercialization.
• Prepare, maintain, and update technical documentation, product registrations, and regulatory submissions for global markets.
• Interpret and communicate regulatory requirements, standards, and guidance documents, including EU MDR, FDA requirements, and ISO standards.
• Partner with Quality, R&D, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated into deliverables.
• Identify regulatory risks and compliance challenges, investigate root causes, and propose practical solutions.
• Contribute to continuous improvement of regulatory processes and quality systems.

Skills

Regulatory affairs

Medical devices

Regulatory submissions

EU MDR knowledge

Analytical skills

Education

Bachelor's degree in Regulatory Science or related field

Job description

BD (Becton, Dickinson and Company) in Limerick, Ireland, is seeking a Senior Regulatory Affairs Specialist to support the infusion preparation and delivery portfolio, ensuring regulatory compliance across the product lifecycle. You will work with Quality, R&D, Medical Affairs and Marketing to enable timely market access for innovative healthcare solutions.

You will interpret EU MDR, UK MDR and FDA requirements, prepare technical documentation, and contribute to continuous improvement of