The Compliance Specialist will oversee regulatory compliance for medical products procured, stored, transported and sold by all companies, currently operating in Ireland, UK and Switzerland, but expected to extend to other EU countries in the future. 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.
Job Responsibilities
* Maintaining Product registrations in all territories for the
* Acting as EUAR for Partners.
* Acting as UKRP for Partners.
* Maintaining EU and country importer licenses for medical devices.
* 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
Qualifications / Experience
* Educated to degree level or equivalent.
* Interest in gaining a Regulatory Affairs Certificate (RAC) in medical devices (or equivalent), with support from 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.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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