Regulatory Affairs specialist

Job description:

Job Title: Regulatory Affairs Specialist Location: Alloa Job Type: Permanent

Company Overview:
Our client is a global leader in medical microwave technology, dedicated to radical innovation in the treatment of HPV infections, dermatology, cardiology, and oncology. With a team of world-class medical microwave experts, our client focuses on designing, developing, and manufacturing microwave applications for various medical fields. Their company is committed to delivering next-generation solutions for today's medical conditions.

Job Description:
Our client is seeking a highly motivated and experienced Regulatory Specialist to join their Regulatory & Quality team. As a Regulatory Specialist, you will play a crucial role in supporting medical device regulatory submissions and ensuring compliance with relevant regulations. You will collaborate closely with cross-functional teams, providing regulatory guidance and contributing to new product development projects.

Key Responsibilities:
Compile regulatory submissions, Technical Files for new products, and changes to existing products and markets.
Provide ongoing regulatory guidance within new product development projects to ensure compliance with applicable regulatory requirements.
Review labelling and marketing material for compliance with relevant regulations and standards.
Support post-market surveillance and vigilance activities, including the submission of reports to authorities.
Stay updated on new and existing regulations, guidance documents, and standards, and prepare comments on their impact on products and business.
Offer regulatory and scientific advice to other areas of the organization.
Develop internal policies and procedures related to regulatory affairs and provide training when necessary.
Review manufacturing changes for regulatory effects and compliance with applicable regulations.
Participate in company regulatory and quality audits.
Report to the Director of Regulatory & Quality.

Required Experience and Qualifications:
Bachelor of Science degree in biology or a similar field from an accredited college or university.
Minimum of 2 years of regulatory experience within a Medical Device or Pharmaceutical environment.
International regulatory affairs experience with a strong understanding of EU MDD/MDR, FDA, Health Canada, and other regional regulations.
Excellent interpersonal, oral, and written communication skills.
Ability to multitask in a fast-paced small company environment and adjust workload based on changing priorities.
Fluent in English.

Additional Information:
Possession of a valid driving license and willingness to travel infrequently.
Must have unrestricted right to work in the UK.

Qualifications:

Qualifications:

• Bachelor of Science degree in biology or a similar field from an accredited college or university.
• Minimum of 2 years of regulatory experience within a Medical Device or Pharmaceutical environment.
• International regulatory affairs experience with a strong understanding of EU MDD/MDR, FDA, Health Canada, and other regional regulations.
• Excellent interpersonal, oral, and written communication skills.
• Ability to multitask in a fast-paced small company environment and adjust workload based on changing priorities.
• Fluent in English.

Why is This a Great Opportunity:

• Innovative Company: The company is dedicated to radical innovation in various medical fields, including HPV infections, dermatology, cardiology, and oncology. By joining this organization, you would have the chance to work on cutting-edge medical microwave technology and contribute to the development of next-generation solutions for medical conditions.
• Impactful Role: As a Regulatory Specialist, you would play a crucial role in supporting medical device regulatory submissions and ensuring compliance with relevant regulations. Your contributions would directly impact the success of new product development projects and help bring innovative medical solutions to market.
• Cross-functional Collaboration: You would have the opportunity to collaborate closely with cross-functional teams within the company. This would enable you to work alongside world-class medical microwave experts and contribute your regulatory expertise to the overall success of the organization.