The Product Surveillance Regulatory Specialist II role contributes to the strategic management of global adverse event reporting, communications with regulators, and risk management activities through the execution of timely, high quality and consistent processes. This role contributes to the on-going improvement of processes, including appropriate identification and response to risks, adverse event reporting decisions, and Field Corrective Actions (FCA) processes.
Ensure decision making and reporting of adverse events meets global regulatory requirements for quality and timeliness.
Actively contribute to the development of divisional policies and procedures relating to adverse event reporting, regulatory communications, risk assessments, and FCAs.
Collaborate with team members, Affiliates and QS Leaders in the execution of FCA processes.
Analyze product complaints holistically and make critical judgments on reportability of adverse events to global regulators.
Analyze product issues holistically and make critical judgments on risk.
Drive activities with cross-functional teams to obtain information necessary for regulatory communications regarding post-market products, adverse event reporting, and FCAs.
Perform data analysis for adverse event reporting activities and for internal reports used to inform decisions and actions to drive improvements in regulatory compliance and customer satisfaction.
Plan, prioritize and perform adverse event reporting and communications with regulators in compliance with global regulatory requirements, Smiths Medical procedures, and customer expectations for quality and timeliness.
Actively contribute to continual process improvements to adverse event reporting, risk assessmnets, and FCA processes to meet customer and regulatory expectations.
Escalate regulatory communications, adverse event reporting, and/or product issues, as necessary.
Provide training and guidance to global complaints database users on use of the database as it pertains to adverse event reporting. Provide training and guidance to cross-functional teams and the Product Surveillance Regulatory Specialist team on adverse event reporting, risk assessments, and FCAs and their related divisional policies and procedures.
Actively participate in training and professional development.
Other duties as assigned, according to the changing needs of the business.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Familiarity with global regulatory requirements as they relate to adverse event reporting, risk management, and FCAs (ie: 21CFR 803, 806, 820, and MEDDEV 2.12).
Analytical skills relative to holistic evaluation and ranking of risks.
Knowledge of risk management associated with medical devices.
Minimum of at least 1 year experience as Product Surveillance Regulatory Specialist I, working with multiple product lines, with demonstrated independent decision making and prioritization skills or equivalent experience
Knowledge of and ability to use personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), and various databases (Oracle, SharePoint).
Ability to use standard office equipment such as, but not limited to, copier, fax, scanner, telephone, and headset.
Bachelor’s degree required (BS/BA strongly preferred).
University Degree (BA degree) required
Excellent proactive problem solving skills.
Ability to communicate effectively with Smiths Medical employees at all levels of the organization.
Effective leadership and facilitation skills to actively participate in cross-functional project teams to drive risk management strategic imperatives.
Ability to analytically assimilate technical information and effectively synthesize and communicate this information to regulatory authorities and internal cross-functional teams.
Ability to analyze and interpret product risk issues and make recommendations to team members and cross-functional teams.
Ability to perform under pressure.
Ability to establish and manage several priorities simultaneously, while meeting multiple deadlines.
Impeccable attention to detail.
Self-directed and self-motivated.
Ability to maintain confidentiality of product complaint information. A working knowledge of the HIPAA privacy regulation is necessary.
Accurate and professional verbal and written communication and presentation skills.
This position makes decisions on the completeness of adverse health outcome or investigation details, pursuing additional information when necessary.
This position uses critical judgment to contribute to decisions regarding risk assessments for critical product issues and FSCAs.
This position makes decisions on adverse event reporting and regulatory communications.
This position uses critical judgment to manage priorities impacting adverse event reporting, regulatory communications, and other risk management activities.
Opinions, information, or erroneous decisions by this position could impact the effectiveness of product complaint investigations, risk management strategies, patient safety, relationships with customers/ regulatory authorities, and Field Safety Corrective Actions.
Incomplete or inaccurate adverse event reports or other regulatory communications could negatively impact regulatory compliance.
Incomplete or inaccurate information could negatively impact Smiths Medical’s relationships with customers and/ or regulatory authorities, resulting in revenue and/ or regulatory compliance implications.
Work is guided by Company policies and procedures, as well as global regulatory requirements and customer needs.
Will interact with global regulators through adverse event reporting and other communications.
Establish effective working relationships with global regulatory authorities.
Establish effective working relationships with cross functional teams.
At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets.
Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.
Smiths Medical is an EEO/AA Employer/Vet/Disabled
If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).