Risk Management SME Contractor

Job Title: Risk Management SME Contractor

Location: Remote

Summary: We are seeking a highly skilled and experienced Risk Management Subject Matter Expert (SME) to join our Design Quality Assurance team. In this role, you will be responsible for performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities. You will collaborate closely with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering teams to ensure compliance with relevant standards and regulations. This position requires strong expertise in risk management and usability engineering, specifically in the context of medical devices.

Essential Duties and Responsibilities: The individual will be responsible for performing the following duties, and must demonstrate the ability to effectively perform each task:

• Conduct thorough gap assessments of existing usability and risk management documentation against EU MDR requirements, ISO 14971:2019, and IEC 62366-1:2015.
• Provide risk management leadership, guidance, and expertise throughout remediation projects.
• Develop and implement efficient processes, procedures, practices, tools, and technologies to foster continuous improvement in risk management.
• Lead the development and implementation of key performance indicators (KPIs) and metrics for the risk management process.
• Support the post-market surveillance team by creating Health Impact Assessments (HIAs) and Health Hazard Evaluations (HHEs).

Qualifications/Experience Required: The ideal candidate will possess the following qualifications and experience:

• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical) or a related field.
• 5-7 years of experience in the medical device industry, with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices.
• Expertise in statistical techniques to calculate probabilities of hazardous situations (p1).
• In-depth knowledge of Usability Engineering and Risk Management practices, processes, tools, and technologies, and an ability to apply these in a medical device context.
• Proven ability to lead and manage risk management efforts in accordance with ISO 14971:2019, MDR requirements, and IEC 62366-1:2015.
• Must Have Skill: Recent experience with ISO 14971:2019 is critical (post-2020).
• Statistical knowledge and familiarity with Minitab are a plus.
• Strong communication skills and the ability to collaborate effectively with cross-functional teams.
• Ability to work during normal business hours.

Additional Skills:

• Strong analytical skills and a deep understanding of medical device regulations.
• Ability to work independently and as part of a team to meet deadlines.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Job ID#511091