JOB SUMMARY
The Compliance Specialist will oversee regulatory compliance for medical products procured, stored, transported and sold by the company. They will also provide advice, research new legislation and business needs and control company registrations with regulators, including HPRA, MHRA, Swiss Medic, EMA and EuDAMED. The post holder will coordinate product compliance data collection and assessment, advising Head of Procurement of compliance (or non-compliance) of new medical devices and products. The postholder will coordinate the collection and calculation of data for Environment, Social and Governance reporting.
KEY ACTIVITIES
* Maintaining Product registrations in all territories for the companies group.
* Acting as EUAR for Partners.
* Acting as UKRP for Partners.
* Maintaining EU and country importer licenses for medical devices.
* Product Commercialisation.
* Managing post market actions and NCA communications.
* Advising the Management team on all aspects of Medical Device and IVD compliance.
* Actively keep up to date with changes to regulations and highlight future changes impact on the business.
* Conducting validation planning, testing and reporting to comply with 21CFR part 11, electronic records, on systems
* storing regulatory required records.
* Coordinate Environmental, Social and Governance Reporting.
EXPERIENCE/QUALIFICATIONS:
* Educated to degree level or equivalent.
* Interest in gaining a Regulatory Affairs Certificate (RAC) in medical devices (or equivalent), with support from the company.
* Good written and verbal communication skills.
* Quality Management and inspection/auditing experience and ideally, certification as auditor.
* 3-5 years' experience in the medical supply market.
* Experience in medical device regulation, or quality management systems auditing.
REQUIRED COMPETENCIES
* Self-starter and ability to work independently on own initiative.
* Completer-finisher with excellent attention to detail.
* Proven organizational skills.
* Team worker.
* Ability to communicate well across all relevant stakeholders.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
Please apply with your CV to:
Robyn Lynch