Regulatory Specialist

Regulatory Specialist
Dunfermline, Fife
Temporary – 12 months

ROLE SUMMARY

We are currently looking for a Regulatory Specialist to join our Regulatory team based in Dunfermline on a 12-month fixed term contract. You will be responsible for implementing and maintaining effective regulatory strategies to achieve compliance and produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with the current state of the art.  Responsibility for all regulatory aspects of the regulatory clearance process for medical devices with responsibility for regulatory submissions globally.  Responsible for the preparation and maintenance of registration files (e.g. STED/Technical Files) in the European Union (EU) in accordance with the Medical Devices Directive 93/42/EEC and future Medical Devices Regulation (MDR), including such areas as US FDA, China SFDA, Japanese MHLW/PMDA, and other national and regional requirements related to the Optos market. Collaborate with global regulatory counterparts to develop regulatory strategy and provide regulatory guidance to project teams. Understand and identify potential risk designs and implications to support product development.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide regulatory expertise in the development and registration of Optos products.
• Communicate effectively with external and internal parties, building strong relationships.
• Responsible for driving 510k, CE and other regulatory documentation and submissions.
• Keeping the business up to date with the latest developments in global regulations.
• Provide regulatory guidance in the development and validation of new and existing products.
• Perform quality review of regulatory documents required for Country approval in accordance with all applicable regulations, guidelines and Optos procedures.
• File and manage all country, national and regional submissions and registrations for all Optos products. Work with distributors to ensure compliance and registration as require din the regions
• Development and maintenance of relevant regulatory policies and procedures
• Act as SME to project teams, other departments and key stakeholders to insure key stakeholders and customers are kept informed on regulations issues which impact their roles and deliverables 
• Perform timely and accurate data entry of regulatory documents and maintenance of Country/Product information in the appropriate management system.

MINIMUM QUALIFICATIONS

• Degree (or equivalent) in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
• Excellent practical experience of  regulatory submissions and requirements.
• Widespread experience in the highly regulated medical device market.
• Good awareness of FDA & MHRA systems and procedures.
• Previous Knowledge of ISO 9001/13485 system is essential
• Knowledge of cGMP / Quality System Regulations is essential
• Direct experience with Medical Device approvals, specifically with clinical trial requirements.
• Excellent presentation skills are required.
• Good computer skills (MS Office applications).
• Experience in Clinical Trials of Medical Devices.
• Fluent English both written and oral is essential
• Minimum level of 6 years of relevant experience in global regulatory affairs and product development or equivalent experience in the global setting
• Valid driver license and passport

BENEFITS

At Optos, we offer a highly competitive compensation and benefits package.

EQUAL OPPORTUNITIES EMPLOYER

We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status.

If you feel you have the necessary skills and experience and want to join a great team, please click on the Apply now button!