Regulatory Specialist

Job Description

Job Title: Regulatory SpecialistLocation: PeterboroughSalary: £60,000 - £70,000 (depending on experience)Summary of Position:Our client, an innovative Med-Tech business is looking for a Regulatory Specialist to join their growing team. The Regulatory Specialist will report to the Head of Quality and Compliance and will be a key aid to the business. As a Regulatory Specialist,you will use your knowledge of the regulatory landscape to ensure products are developed, registered, manufactured, and distributed according to required regulations and standards.The responsibilities include but are not limited to the following:

• Oversee the implementation of a compliant ISO 13485 management system, managing the process through to successful award of certification December 2021.
• Manage and administer a compliant ISO 13485 management system.
• Guide product regulation and translate it into meaningful business requirements.
• Support Regulatory strategy, advising on straightforward and successful routes to markets.
• Gain market access for our regulated products including submissions to UK, EU, FDA regulatory entities as needed.
• Communicate with regional and business teams and prepare responses on all governing agency actions.
• Represent regulatory affairs in new product development to ensure that all regulatory requirements are met throughout the development process.
• Participate in the product release process.
• Participate in regulatory process improvements work.
• Ensures that Design History Files and associated documents are kept up to date.
• Provide specialist direction on QMS Design, Implementation, Maintenance, Risk Management.
• Set up Technical Documentation and Design Dossiers in support of the CE marking process and other International Regulatory compliance processes, including clinical requirements.
• Training of staff in matters related to regulatory approvals.
• Recalls and Adverse Event management.
• Create and maintains regulatory files/database, including technical files.
• Collect and coordinate information and preparation of regulatory documentation for submissions to regulatory agencies and advise on the submission strategy.
• Establish and maintain a tracking system for changes in documents submitted to agencies and/or customers.
• Supports the timely renewal of certificates, licenses, and registrations.
• Creating and maintaining an internal audit programme.
• Assist in the creation and approval of product labelling, TDS, MSDS, and instructions for use (IFU).
• Review and provide regulatory oversight for marketing literature for compliance with relevant regulatory requirements.
• Provide the regulatory review of customer complaints and define their regulatory reportability as needed in post-market surveillance activities.
• Maintain current knowledge of MDR, FDA and international regulations with guidance and standards applicable to company products.
• Monitor CAPA activities internally and externally. Escalate process failures to Senior Management.

Skills, Experience & Key Candidate Attributes:

• Relevant Bachelors degree or relevant demonstrable experience
• Knowledge and awareness of the relevant regulatory guidelines and legislation
• Demonstrable regulatory background and experience
• Knowledge of European, US and Asian markets
• Knowledge of regulatory frameworks (e.g. BPR, MDR, FDA, CE marking, UKCA)
• Experience in International Standards (e.g. 13485 & 14971)
• Knowledge of IEC 60601 series
• Knowledge of design control, software lifecycle and risk management processes
• Experience registering products
• Experience with approval processes
• Ability to work collaboratively
• Enthusiastic and motivated to work in a fast-paced environment
• Strong communication skills both oral and written
• Organisational skills & developing regulatory project management skills

So, if this sounds like you and you want to make a real difference to a growing company, then apply now.

Keyskills :
Regulatory AffairsRegulatory DocumentationRegulatory GuidelinesRegulatory RequirementsTechnical Documentation