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Senior Medical Manager - MEDDEV/MDR Job

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Date: Aug 1, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About this role:

The Medical Senior Manager - MEDDEV/MDR serves to ensure coordinated and efficient completion of all medical aspects of the requirements for technical files related to MEDDEV/MDR.  S/he acts as a strategic partner with colleagues in R&D, Marketing, Clinical Research, Medical Affairs, Regulatory and Health Economics, providing expert scientific input for development and completion of MEDDEV/MEDDEV/MDR related tasks.

 

Your responsibilities will include:

  • Develop expertise and train others in evolving requirements of international regulations, including requirements laid out in MEDDEV and EU MDR.
  • Coordinate and lead efforts to develop and maintain reports and data sets (including Clinical Evaluation Report and Risk Management Documentation deliverables), to support adherence to international regulations and reporting cadence.
  • Individual serves as the medical department’s subject matter expert to support the EU MEDDEV/MDR program for the medical content of internal product documentation and regulatory submissions for new products and for renewals
  • Provides strategic input and shapes clinical aspects related to EU MEDDEV/MDR for the divisions.
  • Develop with key stakeholders a standard response to the changes in EU MDR regulation. The manager will organize and lead the projects and sub-projects needed to ensure compliance with the new regulation and an efficient response from the business, regulatory and evidence generating functions.  This will include:
    • Building strategic framewrk to bridge the evidence gaps while ensuring the businesses can execute growth strategies in the markets impacted by the EU MDR changes or utilize the CER as a base regulatory document
    • Organize immediate effrt to document and map the gaps in the current evidence needs to plan for resources and budget going forward
    • Drive sub-prject planning & management reviews to meet EU MDR timelines and budget requirements, directing resurces to realize milestones and Key Performance Indicators (KPI’s) utilizing problem solving tools and/or lean tools and methodologies.
    • Help identify key pririties and decisions to enable the organization to capture key opportunities to reduce risk, develop mitigation strategies and improve performance
    • Design & implement central prject management tools/templates (SharePoint, trackers, etc.), support lessons learned driving consistency and alignment across businesses, workstreams and taskforces with peers
    • Leverage well develped interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization and coaching others
    • Supprt internal program and external BSCI communication, which includes content and planning for communications cascades, and supporting review / feedbackPartners with clinical evaluation and PMS teams to understand and assess evidence needs and provides insights into the development of clinical strategies for MEDDEV/MDR compliance.
  • Collaborates closely with divisional medical directors for clinical activities for the MEDDEV/MDR program and evidence needs
  • Aligns implementation of MEDDEV/MDR evidence requirements into the global evidence generation strategy (EGS) and execution plan.
  • Collaborates with Divisional and Regional Medical and Clinical and others to ensure EMEA evidence needs are understood and input for global EGS and evidence dissemination.
  • 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.
  • Provides guidance into Design History Files, Technique Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files.
  • Works with owners of the following documents and helps optimize processes for development of technical documentation including study protocols, study reports, PMCF (post-market clinical follow-up) plans, and PMCF reports.
  • Provides domain expertise to support Medical Safety and Quality when needed in the evaluation of Post-Market Surveillance data or Adverse Events.

 

What we're looking for in you:

Minimum qualifications

  • Bachelor’s degree in healthcare/life science related field
  • 7+ years of related work experience in clinical trials, clinical research, and/or clinical quality.
  • Medical Devices experience
  • Management experience
  • Knowledge of Regulatory pathways, EU MEDDEV/MDR and MEDDEV related to pre- and post-market evidence needs
  • Ability to provide scientifically strategic and scientific clinical research input
  • Must be able to collaborate well with multiple partners and work effectively in a matrix environment
  • Ability to collaborate across different functional areas within Medical, Clinical, Regulatory, Medical Operations to ensure alignment with governance processes and to meet business objectives
  • 20-30% domestic travel

Preferred qualifications

  • Advanced degree (Master’s degree and above) or Medical/Nursing Degree preferred. Healthcare related background
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholder
  • Able to work independently to solve complex issues
  • Demonstrated knowledge in quality compliance, regulatory compliance and healthcare compliance is preferred
  • 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 preferred
  • Previous industry experience working with Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business preferred
  • Strategic thinker able to develop and execute new evidence generation concepts

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 450251

 


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