Regulatory Manager

Job Description

PageGroup are currently looking to hire a strong Regulatory Affairs Manager for our retained client Emblation, based in the Central Belt of Scotland, to help drive growth targets within the UK and Globally.Client DetailsPageGroup Scotland are delighted to be supporting emblation - an award-winning medical technology company, revolutionising the way microwave energy is used in healthcare. Their aim is to improve on traditional treatments, using the unique advantages microwavesdeliver - accurate, repeatable procedures, and better clinical outcomes.Their technology is revolutionising the treatment of HPV infections globally, and is widely used in Dermatology, Podiatry and Oncology, with a number of disruptive applications under development in the fields of Cardiology and Gynaecology.The company was started in 2007 by joint co-founders (current Chief Executive Officer and Chief Technology Officer) and inventors behind the technology. They form part of the highly experienced management team with over 50 years of experience in this field.You can now find emblations medical devices in 1000s of clinics and hospitals across the UK, the US, Canada, and Australia. They are just at the start of a journey and you will be joining the emblation team at a key phase in their growth. Having recentlysecured additional investment into the business to fund the next stages of the companys development, underpinned by 3 primary goals:

• Expansion into new treatment areas
• Development of new markets and a wider global presence
• The addition of new talent to our Scottish Headquarters to bring the skills and experience needed to support our plans for growth

The next five years will be excitingDescriptionThe role will mainly be responsible for managing Medical Device regulatory submission and regulatory compliance activities.Your deliverables will include the following:

• Determine the scope of information & documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
• Identify regulatory requirements for new product and changes to existing products & markets.
• Contribute within new product development projects to provide ongoing regulatory guidance and ensure compliance with relevant regulatory requirements.
• Assist in the design and development of clinical trial activities.
• Review labelling/marketing material for compliance with applicable regulations and standards.
• Support post-market surveillance and vigilance activities, including submitting reports to authorities.
• Review new and existing regulations, guidance documents & Standards, and prepare comments based on impact to product and business.
• Provide regulatory and scientific advice to other areas of the Organisation.
• Develop regulatory affairs internal policies and procedures, and provide training as and when required.
• Review changes in manufacturing for regulatory effects and compliance with applicable regulations.
• Participate in company regulatory/quality audits.

Profile

• Bachelor of Science Degree in biology or similar field is essential
• Proven track record in Regulatory & Quality Affairs in Medical Devices.
• International regulatory affairs experience with a thorough understanding of EU MDD/MDR, FDA, Heath Canada and other regional regulations.
• Proven success implementing regulatory strategy for new product introductions, new market introductions and changes in regulatory requirements.
• Excellent interpersonal, oral and written communication skills, planning and organisational skills with effective time management and excellent presentation skills.
• Effective communication with regulators to negotiate the requirements of the submitted data and delivery times.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• This role will require infrequent travel so a driving license is required.

Job OfferExcellent dependent on experience