Overview
At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We’ve been recognised as a Great Place to Work, and named among the Best Workplaces in Healthcare and Best Workplaces for Women.
At Eakin Healthcare, we’re united by one mission: working together to improve lives - just like we’ve been doing for over five decades.
Why join us
* Blended Working
* Bonus
* 25 days holiday plus bank holidays (rising to 28)
* Option to buy holiday days
* Wellbeing Programme
* Health Cash Plan
* Pension
* Life Assurance
* Enhanced Maternity/Paternity
* Cycle to Work Scheme
* Referral Scheme
* Long Service Awards
* Free Parking
About the role
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist, based from either the Cardiff or Comber site, is responsible for supporting the group in ensuring requirements for medical device regulatory compliance are identified, achieved and maintained.
Key responsibilities
* Regulatory Compliance
o Maintain medical device technical files in line with current regulatory requirements.
o Generate reports relating to device sales, complaints and other post-market data.
o Analyse and trend Post Market Surveillance (PMS) data; compile and distribute PMS reports.
o Create and maintain appropriate regulatory documentation on relevant e-QMS and document management systems, as required.
o Ensure adequate control and maintenance of regulatory documentation and procedures.
o Ensure regulatory compliance is integrated into New Product Development (NPD) projects and complete assigned regulatory tasks.
o Implement and maintain changes in regulatory legislation that affect the Quality Management System.
o Contribute to the continual improvement of regulatory affairs processes and systems.
o Support the Regulatory team in achieving and maintaining compliance with EU MDD, UK MDR, EU MDR, ISO 13485, MDSAP and other national regulatory requirements in countries where our products are used.
o Conduct regular risk management activities, including product-related risk assessments, to ensure compliance with ISO 14971 requirements.
o Assist the Regulatory Affairs Manager during routine and unannounced internal / external audits.
o Maintain effective communication and relationships with regulatory authorities.
* Scheduling and monitoring
o Maintain the Regulatory Schedule in line with Post Market requirements and Periodic review requirements, including but not limited to PMS / PSUR, Clinical Evaluation, Economic Operator Mandates etc.
o Monitor and evaluate regulatory updates from external sources (e.g. Standards, Common Specifications, MEDDEVs, Industry guidance) and communicate the relevant changes to the team.
* Device registration
o Maintain annual registrations with Regulatory Authorities such as the US FDA and others as required.
o Compile plans and reports required to support product approvals submissions.
o Respond to internal and external requests for technical or regulatory information, including support for device registrations and licencing.
* Vigilance / Recall
o Conduct vigilance activities and assist in the reporting and monitoring of adverse events to the appropriate authorities.
o Prepare and submit adverse incident reports in a timely manner.
o Execute activities related to Field Safety Corrective Actions, as required.
o Liaise with business partners, distributors and other entities in relation to vigilance and recall activities.
* Other
o To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
o To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s Health and Safety policy
o To adhere to the company’s Quality policy and Environmental policy
o To undertake other duties as may be reasonably required
What we’re looking for
Essential
* Degree educated in science, business, law or proven experience in a similar
* Previous experience in a regulatory role
* Strong administration skills
* Meticulous with high levels of attention to detail
* Ability to work under pressure and to tight deadline
* Effective team player with strong communication skills
* Proficient in MS office
Desirable
* Experience with ostomy medical devices.
* Previous experience in medical device
* Knowledge of EU MDD, EU MDR, UK MDR, ISO13485 and/or MDSAP.
* Experience carrying out risk
Key working relationships
Internal
* Operations
* QARA Teams
* R&D
* Commercial Teams
External
* Regulatory authorities
* Notified Body/Approved Body
* Customers, Distributor, Importers and Authorised Representatives
* Suppliers
Additional information
* Occasional travel to other Eakin Healthcare sites may be required
* Ability / willingness to attend training courses in relation to the role and the needs of the department
* Ability / willingness to develop within the role
Competencies
* Ensures accountability
* Collaborates
* Manages complexity
* Decision quality
* Interpersonal savvy
* Being resilient
* Situational adaptability
* Optimizes work processes
#SJ
#J-18808-Ljbffr