Medical Director

Troy - Michigan - United States - Life Sciences & Health Care - Medical devices - Medical - Other

We’re hiring a Medical Director for our client, a large medical devices company, to join their team. This is a one-year contract with long-term potential.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Individual serves as the medical subject matter expert to support the EU 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 of EU MDR for DePuy Synthes;
  • Partners with clinical evaluation and PMS teams to understand and assess evidence needs and develops clinical strategies for MDR compliance;
  • Collaborates closely with FMD for clinical activities and complex projects for the MDR program and evidence needs;
  • Aligns implementation of evidence requirements into the global evidence generation strategy (EGS) and execution plan;
  • Collaborates with Franchise and Regional Medical and Clinical and others to ensure EMEA evidence needs are understood and input for global EGS and evidence dissemination;
  • Closely collaborates with business leaders, the Franchise EGS teams, Medical Operations, Biostatistics, the Evidence Generation Council to ensure evidence needs and gaps are understood, reviewed and strategies are implemented for the DePuy Synthes portfolio;
  • Supports the PCM Leader to develop and deliver appropriate clinical evidence generation and dissemination strategies to support products within DePuy Synthes;
  • 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;
  • Authors, edits, and approves Design History Files, Technique Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files;
  • Develops 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;
  • Provides medical input and expertise in the analysis of study results;
  • Supports the PCM Lead for strategic clinical and scientific input for meetings with Notified bodies and authorities.

About you

Requirements

  • A minimum of an MD/MB/DO or equivalent is required; additional advanced degrees preferred;
  • Current license to practice is required and ability to continuously maintain licensure is required;
  • Current US Board Certification by American Board of Neurological Surgery or American Board of Orthopedic Surgery is required and ability to maintain certification moving forward is required;
  • A minimum of 10-years relevant operative experience in either orthopedic or neurological spine surgery and/or cranial neurological surgery beyond post graduate medical education (including: specialty residency, fellowship or subspecialty training). Namely, 10+ years of independent clinical practice with substantial operative experience and judgement;
  • Medical Devices experience and focused in the specific therapeutic area(s) above is required;
  • Knowledge of US and OUS Regulatory pathways, FDA, EU MDR and MDD related to pre- and post-market evidence needs preferred;
  • 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 is required;
  • Ability to provide scientifically strategic and scientific clinical research input required;
  • Previous industry experience working with Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business preferred; 
  • Membership and leadership roles in specialty Professional Societies is desirable;
  • Must be able to collaborate well with multiple partners and work effectively in a matrix environment;
  • Strategic thinker able to develop and execute new evidence generation concepts;
  • Ability to collaborate across different functional areas within Medical, Clinical, Regulatory, Medical Operations to ensure alignment with governance processes and to meet business objectives;
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB218750
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Medical devices
  • Education level: Other
  • Area of Expertise: Medical
  • Closing date: Saturday, August 10, 2019
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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