Regulatory Affairs Manager

Hartley People

Waterford, Tipperary

SteriMed are an Amercian based company. They have patented two systems that convert Medical Waste to Ordinary Waste. Therefore reducing the costs to have this waste collected and disposed of correctly. It can all be done on site and any member of staff can be trained to use the machine. These two machines are manufactured here in Waterford. SteriMed are now looking to employ a Regulatory Affairs Manager on site in Waterford. Hartley People are exclusively recruiting for this exciting opportunity. This person will look after all regulatory issues that arise and achieve Regulatory Compliance for the product in each state / country that is released in. SteriMed are a rapidly growing company, there is great potential for person joining the team in Waterford. The Role: Maintain existing registrations for the Company’s Proprietary Disinfectant and Waste Treatment Technology in territories outside of the USA. Develop work plans and put forth required effort to manage existing approvals in the UK, and to obtain product registration and approvals throughout the EU, Russia, India, Japan, the Middle East, and Africa (the “Territories”) Create, manage, and submit documentation and applications to various Regulatory Agencies in the Territories to obtain product approval. - Develop testing protocols with Regulatory Agencies in each of identified countries with the Territories for the validation and approval-for-use of the Company’s waste treatment products. - Coordinate as required with independent laboratories which may be required to perform certain validation tests in support of applications for approval of the Company’s technology in the countries identified. - Coordinate language translation of Company’s existing validation reports as required by local country requirements. Support Team Building within Global Entity - Act as key liaison with the Company’s US-based regulatory affair department clients to ensure technology transfer on all regulatory issues inclusive of sharing of the body of existing technical evidence and studies regarding water treatment, landfill , and state-level microbiological efficacy testing. Proactively prevent business disruptions due to regulatory compliance issues or customer dissatisfaction. Prepare and present regulatory status reports and new regulatory requirements when known. Reporting Project Management. Toxicology/Industrial Hygiene. UK Health and Safety Compliance. Due diligence for Hazard & Risk Assessment Activities including COSSH. Export controls for regulated antimicrobials into USA from Ireland warehouse. Import controls and logistics for regulated biocide pesticides into Ireland from production sources in the EU. Management and Coordination of Biocide Pesticide Registration within the EU. Maintenance of REACH Compliant SDS Documentation Company’s proprietary disinfectant. The Person: Education – Level 8 (minimum) or Level 9 (preferred) Degree in Environmental Science, Chemistry, Biology, Microbiology or Medicinal Chemistry preferred preferably in the waste management, environmental industry demonstrating sound knowledge in working with chemicals/chemical lab packing. Minimum of 5+ years of extensive environmental, health and safety (EHS) and regulatory affairs compliance. Experience in specialty hazardous and special waste compliance industry (i.e. water and process treatment for microbiological efficacy) is a plus. Must pass certain regulatory and environmental certifications during 180 day introductory employment period, including UK WAMITAB (Waste Management Industry Training ) Effective leadership & managerial skills. Strong multi-tasking and professional writing skills. Demonstrates strong working knowledge of Environmental/Regulatory/DOT rules and regulations. Strong communication and presentation skills. Global travel may be required to attend meetings or to perform initial validation testing in local independent laboratories to obtain regulatory approvals in each territory. US EPA-FIFRA experience required, or must pass EPA FIRFA competency examination provided by company within the 90 day introductory period. Very proficient in Microsoft Office (Work, Excel, Outlook, Power Point. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For more information on this role and immediate consideration please call Brenda Duffy on 051-878813 or email your CV in a word document to brendaduffy@hartleypeople.com.

3472 days ago