Regulatory Affairs Engineer

Responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of Cyclomedica products globally.

Main Duties: 

•           Negotiating with regulatory authorities for marketing authorisation;

•           Liaising with, and making presentations to, regulatory authorities;

•           Collecting, collating and evaluating scientific data that has been researched by colleagues;

•           Developing and writing clear arguments and explanations for new product licences and licence renewals;

•           Preparing submissions for licence variations and renewals to strict deadlines;

•           Ensuring that Cyclomedica’s products comply with regulations;

•           Keeping abreast of international legislation, guidelines and customer practices in all countries that Cyclomedica is exporting to;

•           Monitoring and setting timelines for licence variations and renewal approvals;

•           Specifying storage, labelling and packaging requirements;

•           Writing clear, legible product labels and patient information leaflets;

•           Providing strategic advice to senior management throughout the development of new products / product changes;

•           Project managing teams of colleagues involved with the development of new products / product changes;

•           Undertaking and managing regulatory inspections;

•           Planning and developing product trials, including stability testing, and interpreting trial data;

•           Advising colleagues on regulatory requirements;

•           Working with specialist computer software and resources;

•           Reviewing company practices and providing advice on changes to systems;

•           Overseeing regulatory responses following external inspections;

•           Managing and directing agents engaged for pharmacovigilance, Authorised Representative(s) and Responsible Person(s);

•           Ensuring change management incorporates and considers regulatory impact;

•           Assisting with reporting post-market data to regulatory authorities i.e. recalls, adverse events, major changes.

Qualifications & Experience:

• Tertiary qualification in Science or Engineering, Masters Degree preferred & minimum 4 years Regulatory Affairs experience in the medical device industry

Essential skills: 

•           Able to work with minimal supervision with exceptional planning skills prioritising work

requirements to meet deadlines in fast-paced environment whilst maintaining a strong attention to detail

•           Strong analytical and problem solving skills, excellent attention to detail and a commitment for compliance processes

•           Strong written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders

• Flexible hours available
• More than 4 years of relevant work experience required for this role
• Work visa can be provided for this role
• Expected start date for role: 01 March 2024