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25 days old

MDR Manager - Remote Based!

Kelly Services
Raynham, MA 02767
Kelly Services Outsourcing & Consulting Group (OCG) is seeking an MDR Manager for a long-term, open-ended assignment with benefits. The position can be remote based anywhere in the U.S. but will require initial training to be done onsite (location TBD).





The MDR Manager is a member of the Medical Affairs team providing medical and scientific input for development of MDR related tasks. Candidates must have medical device experience and a background in Ortho, Sports, Joints, General Practice, Physical/Sports/PC Medicine. Experience in quality compliance, regulatory compliance, and healthcare compliance is preferred





POSITION DUTIES & RESPONSIBILITIES:





Serves as a medical subject matter advisor for the EU MDR program relative to medical content of internal product documentation and regulatory submissions for new products and for renewals.



Partners with Medical Director working with the Clinical Evaluation and PMS teams to understand and assess evidence needs and develops clinical strategies for MDR compliance. Provides strategic input to shape the clinical aspects of EU MDR.



Collaborates with Medical Affairs, Pre-Clinical, Clinical, Medical Operations, Regulatory, Biostatistics and others to ensure evidence needs and gaps are understood, reviewed and strategies implemented for the Customer portfolio. Provides input for Global EGS and evidence dissemination; aligns evidence requirements with the global evidence generation strategy (EGS) and execution plan.



Supports the Medical Director(s) in medical oversight of appropriate clinical evidence generation, dissemination and publication strategies in support of Customer products in close collaboration with the cross functional team.



Provides input to cross functional team in support of evidence assessment, literature review, analysis and conclusions for Clinical Evaluation Reports (CER). Works with Regulatory and Clinical partners to prepare reports on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements.



Reviews CERs and assists in preparation of periodic safety reports for assigned products.



Reviews Design History Files, Surgical Technique Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files.



Develops/manages technical documentation including study protocols, study reports, PMCF (post-market clinical follow-up) plans and PMCF reports. Prepares presentations and manuscripts around clinical data as well as medical and scientific information, this includes hands on management of publications and maintenance of timelines.



Provides domain expertise to support Medical Safety and Quality when needed in the evaluation of Post-Market Surveillance data or Adverse Events.



Provides medical input from the surgical perspective and expertise in the analysis of study results.



Assesses work volumes, effectively prioritizes business needs to meet the demand, and escalates work load constraints accordingly to Medical Directors.





EDUCATION & EXPERIENCE REQUIREMENTS:



Minimum of five or more years in clinical, engineering or life science experience required; some direct patient contact is preferred, operating room experience a plus



PA, NP, RN, PhD with a background in Ortho, Sports, Joints, General Practice, Physical/Sports/PC Medicine; Medical Degrees (MD, DO) may be considered under special circumstances



Medical Devices experience and focused training in specific therapeutic area(s) required



Knowledge of regulatory pathways, EU MDR and MDD related to pre- and post-market evidence needs



Demonstrated knowledge in quality compliance, regulatory compliance and healthcare compliance



Clinical experience with medical devices and knowledge of clinical research science, clinical trends, clinical processes, clinical trial design and regulations, evidence generation, adverse event reporting, surgical practices/principles



Ability to provide scientifically strategic and scientific clinical research input required



Ability to collaborate across different functional areas within Medical Affairs, Clinical, Regulatory, Medical Operations to ensure alignment with governance processes and to meet business objectives



Some domestic travel required; first month will be onsite while training, otherwise remote



Excellent communication and presentation skills are essential. Fluency in English both written and spoken is required.



Fluency with Microsoft Office (Word, PowerPoint, Excel, & Outlook) essential





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





This position comes with enhanced benefits which include:



50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%) *



Paid sick days and vacation days*





Perks of being a Kelly employee:



Weekly electronic pay



Access to more than 3,000 online training courses though Kelly Learning center



Online application system



Never an applicant fee





*benefits to be received upon meeting eligibility requirements






**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-18 Expires: 2019-11-18

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MDR Manager - Remote Based!

Kelly Services
Raynham, MA 02767

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