Regulatory Affairs Specialist

Job Description

We are seeking a Regulatory Affairs Specialist to join our Worcester team. The successful candidate will be responsible for overseeing compliance with regulatory requirements related to product development, ensuring that all processes align with both national and international standards.

Responsibilities

• Review product development documentation and ensure compliance with regulatory frameworks.
• Assist with post-market surveillance and reporting obligations.
• Liaise with regulatory agencies during audits and inspections.
• Develop and implement strategies for regulatory compliance initiatives.
• Provide regulatory guidance to product teams throughout the product lifecycle.

Requirements

Education

• Bachelor's degree in Life Sciences, Pharmacy, or a related field
• Relevant postgraduate degree is an advantage

Experience

• 3-5 years in regulatory affairs with a focus on healthcare products

Technical Skills

• Regulatory Strategy Development
• Risk Assessment

Soft Skills

• Analytical Skills
• Teamwork

Certifications

• Regulatory Affairs Certification (RAC)
• Certified Quality Auditor (CQA)

Languages

• English: Fluent

Advantageous

• Expertise in Quality Management Systems (QMS): Hands-on experience with quality management systems applied in regulatory settings.
• Familiarity with International Regulations: Knowledge of international regulations and their impact on product development.

Benefits

• Generous vacation and leave policies
• Health and wellness programs
• Retirement plan with employer contribution
• Support for ongoing education and training

Company Culture

• Diversity: We celebrate diversity and inclusion, committed to building a workforce that reflects the communities we serve.
• Employee Engagement: We prioritize employee engagement, supporting personal and professional growth in our team members.
• Continuous Learning: Our team members are encouraged to pursue ongoing learning and development opportunities.