Product Surveillance Medical Specialist at Smiths-Medical in Minneapolis, Minnesota

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PRODUCT SURVEILLANCE MEDICAL SPECIALIST

Location
North America, USA, Minnesota, Minneapolis

Job Reference
MEDNA01044

Job Type
Full Time

Job Function
Reg Affairs & Quality Assurance

Job Description

Smiths Medical is currently hiring a Product Surveillance Medical Specialist in Minneapolis, MN.

The Product Surveillance Medical Specialist will contribute 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 primarily reviews adverse event reporting decisions and also contributes to the on-going improvement of processes, including appropriate identification and response to risks.

Smiths Medical has a positive impact on someone s life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline. Duties & Responsibilities

* Conduct review of all serious adverse event complaints as well as non-reportable complaints to ensure correct reportability.

* Ensure decision making and reporting of adverse events meets global regulatory requirements for quality and timeliness.

* Document clear rationale s for both reportable and non-reportable complaints.

* Analyze product issues holistically and make critical judgments on risk.

* 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.

* Actively contribute to continual process improvements to adverse event reporting and risk assessments to meet customer and regulatory expectations.

* Escalate regulatory communications, adverse event reporting, and/or product issues, as necessary.

* Provide training and guidance to cross-functional teams and the Product Surveillance Regulatory Specialist team on adverse event reporting and Risk assessments 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.

Diversity & Inclusion

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. The Individual

* Bachelor s degree in Nursing required. Prior nursing experience of 1-3 years, preferably in the areas of Intensive Care Unit, Respiratory Care or Operating room.

* Active RN License required.

* Prefer at least 1 year medical device experience, in a complaint handling role, working with multiple product lines, with demonstrated independent decision making and prioritization skills or equivalent experience.

* Ability to use standard office equipment such as, but not limited to, copier, fax, scanner, telephone, and headset.

* Knowledge of and ability to use personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), and various databases (Oracle, SharePoint).

* Knowledge of risk management associated with medical devices.

* Analytical skills relative to holistic evaluation and ranking of risks.

* Familiarity with global regulatory requirements as they relate to adverse event reporting and risk management (ie: 21CFR 803, 806, 820, and MEDDEV 2.12).

* Accurate and professional verbal and written communication and presentation skills.

* Ability to maintain confidentiality of product complaint information. A working knowledge of the HIPAA privacy regulation is necessary.

* Self-directed and self-motivated.

* Impeccable attention to detail.

* 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.Education requirements can be obtained through an educational institution or gained through equivalent work experience.

Salary & Benefits

In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more! About Smiths

At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.

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).

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