Regulatory Affairs Manager

Job description:

Job Description: Regulatory Affairs Manager Location: Alloa Type: Permanent

Your New Company:
Our client an award-winning medical technology company revolutionizing the way microwave energy is used in healthcare. Their mission is to improve traditional treatments by leveraging the unique advantages microwaves offer, including accurate, repeatable procedures and better clinical outcomes. Their technology is transforming the treatment of HPV infections worldwide and is widely used in Dermatology, Podiatry, and Oncology, with disruptive applications under development in Cardiology and Gynaecology. Founded in 2007 by their joint co-founders, who are inventors and part of their highly experienced management team, they have over 50 years of combined experience in the field. Their medical devices can be found in thousands of clinics and hospitals across the UK, the US, Canada, and Australia. They have recently secured additional investment to support their expansion into new treatment areas, development of new markets, and the addition of new talent to their Scottish Headquarters. Join them now for an exciting journey ahead.

Your New Role:
To support our client's expansion and growth, they have a great opportunity for a Regulatory Manager within their Regulatory & Quality team. As the Regulatory Affairs Manager, you will be primarily responsible for managing medical device regulatory submissions and regulatory compliance activities. Your role will include the following deliverables:
Determine the necessary information and documentation required for new registration applications and post-approval changes to regulatory agencies.
Identify regulatory requirements for new products and changes to existing products and markets.
Provide ongoing regulatory guidance and ensure compliance with relevant regulatory requirements within new product development projects.
Assist in the design and development of clinical trial activities.
Review labeling and marketing material for compliance with applicable regulations and standards.
Support post-market surveillance and vigilance activities, including submitting reports to authorities.
Stay updated on new and existing regulations, guidance documents, and standards, and provide comments based on their impact on products and business.
Provide regulatory and scientific advice to other areas of the organization.
Develop internal policies and procedures for regulatory affairs and provide training when necessary.
Review changes in manufacturing for regulatory effects and compliance with applicable regulations.
Participate in company regulatory and quality audits.
What You Will Need to Succeed:
You will be an energetic, passionate self-starter with a positive disposition, thriving in an environment focused on growth and the necessary changes to achieve it. In addition, we are looking for an individual with the following capabilities:
Bachelor of Science degree in biology or a similar field from an accredited college or university.
A minimum of 5 years of experience in Regulatory & Quality Affairs in the medical device industry.
International regulatory affairs experience with a thorough understanding of EU MDD/MDR, FDA, Health Canada, and other regional regulations.
Proven success in implementing regulatory strategies for new product introductions, new market entries, and changes in regulatory requirements.
Excellent interpersonal, oral, and written communication skills, along with strong planning, organizational, and time management abilities.
Effective communication with regulators to negotiate requirements and delivery times for submitted data.
Comfortable multitasking in a fast-paced small company environment and able to adjust workload based on changing priorities.
Fluent in English.
This role will require infrequent travel, so a valid driving license is required.

What You'll Get in Return:
Salary: XX,XXX
Pension: 3% Employer's Contribution
Annual Leave Allowance: 33 days (including bank holidays)
Private Healthcare
We look forward to hearing from you!

Qualifications:

You will be an energetic, passionate self-starter with a positive disposition, thriving in an environment focused on growth and the necessary changes to achieve it. In addition, we are looking for an individual with the following capabilities:

• Bachelor of Science degree in biology or a similar field from an accredited college or university.
• A minimum of 5 years of experience in Regulatory & Quality Affairs in the medical device industry.
• International regulatory affairs experience with a thorough understanding of EU MDD/MDR, FDA, Health Canada, and other regional regulations.
• Proven success in implementing regulatory strategies for new product introductions, new market entries, and changes in regulatory requirements.
• Excellent interpersonal, oral, and written communication skills, along with strong planning, organizational, and time management abilities.
• Effective communication with regulators to negotiate requirements and delivery times for submitted data.
• Comfortable multitasking in a fast-paced small company environment and able to adjust workload based on changing priorities.
• Fluent in English.

This role will require infrequent travel, so a valid driving license is required.

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.