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Project Manager, EU MDR, Regulatory Affairs - Device Labeling

Company: DivIHN Integration Inc
Location: Deerfield
Posted on: January 12, 2022

Job Description:

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program. - Check out our careers page to see all of our job openings: - One of our BEST F500 customers has engaged us to help them hire a -Project Manager, EU MDR, Regulatory Affairs - Device Labeling to be available -to work out of their office in Deerfield, -Illinois; details can be found below. 11 months Please apply or call one of us to learn more For further information please contact our Talent Specialist:

  • Vivek - (630) 847 1949.
  • Arjun-(630) 847 7717 Title: Project Manager, EU MDR, Regulatory Affairs - Device Labeling Duration: 11 months Location: Deerfield, IL What is the expected work schedule? Monday to Friday, With the current hybrid model in the office Tues-Thursday, 9-5 pm, can be flexible on start/end times Is this onsite or remote Onsite-Deerfield. However, if we are only able to find someone remote we may consider If onsite will it be a hybrid model? Yes What are the top three to five technical skill requirements? Seeking a Regulatory Affairs professional with global/MDR or MDD (Medical Device Directive) labeling experience Experience with CE Marking and European Union Medical Device Regulations ( EU MDR) Experience with Redlining medical device product labeling to country requirements Development of labeling requirement specifications, requirements traceability Subject matter expert in MDD/MDR product labeling Command of labeling standards such as ISO 15223, ISO 60601-1 What are your top three to five soft skill wants? An active listener with strong verbal and written communication skills Negotiation skills Requires Problem-solving skills for creative thinking to find solutions and have the ability to make sounds risk-based decisions High level of business acumen Ability to identify and communicate potential compliance issues and escalate as necessary. Self-starter with strong time management skills What is the expected interview process? Would like to prescreen then do interviews with a small team. Wanting to start as soon as possible. Description In collaboration with cross-functional teams, the incumbent provides guidance and subject matter support to RA project teams to facilitate regulatory compliance for EU MDR (EU Medical Device Regulation) in the most effective risk-based method. Provides leadership and guidance and subject matter support to offshore and onshore project contractors. In collaboration with cross-functional teams, will be responsible for driving global device labeling initiatives to support the EU MDR remediation project objectives. Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies. Formulate and drive global labeling traceability requirements within project and product teams. Represent or lead the RA labeling function on assigned cross-functional project teams and projects to develop global device labeling requirements and labeling content. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team. Monitor applicable global regulatory and labeling requirements; assure compliance with client and external standards and help drive implementation across functions and projects. Effectively assess the impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance. Effectively perform labeling gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications. Develop and maintain effective cross-functional partnerships and networks within RA and key stakeholders including Marketing, RandD, QA, Supply Chain to drive key EU MDR labeling strategies and initiatives. Ensure project teams and business objectives and deliverables are aligned with project regulatory labeling strategy Lead group of regulatory professionals in labeling gap assessments to EU MDR requirements and the further development of labeling requirements documents per MDR project timelines Provide direct supervision and mentoring of project team members during the project. Provide project performance feedback to the team member's supervisor/manager Assist in the formulation and execution of regulatory labeling strategies/ project plans Develop and communicate guidance for EU MDR, global and regional regulatory and customer labeling requirements. Monitor evolving regulatory requirements and ensure compliance programs are appropriate and meet requirements Perform/review labeling gap assessments and provide remediation guidance and strategies Develop and review labeling requirement specifications for remediated products Monitors work output of contractors to define and execute additional training Develop and report periodically metrics for assigned work projects. Qualifications: Extensive knowledge of medical device regulatory requirements for the EU MDR (Medical Device Regulation), and other global Device Labeling requirements, such as from standards. Ability to identify and communicate potential compliance issues and escalate as necessary. Prudent risk-taker. Strong business acumen. Strong oral, written communication, and presentation skills. Demonstrated interpersonal skills including strong negotiation and facilitation skills. Demonstrated leadership skills and experience with coaching others. Strong project management and organizational skills. Proven track record of delivering large-scale projects. Ability to manage complex projects and timelines in a matrix team environment. Education / Experience Bachelor's degree in biological sciences, engineering or related field preferred. Five or more years' experience in medical device Regulatory Affairs. Direct experience with global device labeling will be an advantage. Minimum of five years professional experience managing people or projects. Regulatory Certifications such as RAPS a plus About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status. Job Requirements:MDD, MDR product labeling

Keywords: DivIHN Integration Inc, Arlington Heights , Project Manager, EU MDR, Regulatory Affairs - Device Labeling, Executive , Deerfield, Illinois

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