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Director, Product Risk Job

Remote Eligible:  Onsite
Onsite Locations(s): 

Marlborough, MA, US

Additional Locations:  N/A

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
The Clinical Product Risk Director provides strategic, performance and people leadership for the Urology Pelvic Health Clinical Product Risk Management team. They have comprehensive leadership and technical skill sets and a thorough understanding of the relevant therapeutic areas as it relates to the evaluation of risk for medical devices. They oversee strategy and execution of clinical evidence report writing and post market clinical follow-up reports. They provide innovative solutions and lead resolution of organizational issues and process improvement efforts through analysis and cross-functional collaboration. They are a functional SME and represent their function to internal cross-functional partners and external stakeholders, while also recruiting, training and managing a team of Product Risk Specialists and PMCF specialists. The Director of Product Risk reports directly to the Urology & Pelvic Health Chief Medical Officer.

 

Your responsibilities will include:

  • Execute, lead and train others on all aspects of Clinical Evidence curation and Risk Management research, analysis, interpretation and document generation.  Identify issues, develop and communicate proposed solutions to teams and senior management as required.
  • Leads the development of clinical risk strategy by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout product development and implementation of local or global Regulatory requirements.
  • Provides clinical input for new product development, post market surveillance, PMCF, recertification and business development.
  • Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.
  • Facilitates clinical risk communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, by conducting cross-functional team meetings, and by presenting regular updates to senior staff (BPT/PIB, etc.).
  • Manages clinical risk timelines required by global Regulatory Bodies by utilizing the appropriate project management tools.
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
  • Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.
  • 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.
  • Independently utilize understanding of therapeutic area to identify and interpret information impacting risk management and no clinical trial justification reported in the literature.  Lead junior staff through process and author clinical evaluations in support of no clinical trial justification.
  • Identifies functional area specific project risks.  Develops and executes contingency and mitigation plans for programs.  Work with contractors and/or vendors to complete work as necessary and ensure compliance to training, corporate standards and regulatory agencies.
  • Serves as Risk Management SME on project team; makes decisions and clearly communicates pertinent project/function information.  Determines clinical and cross-functional resources and expense requirements for team.  Collaborates with functional manager on quarterly budget issues.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.  Negotiate resource utilization to ensure deliverables are met within timeline and budget.
  • Identify, propose and lead process improvements within function.  Develop best practice guidelines to support company or US/OUS regulatory standards and contribute to development of functional SOPs and WIs.  Influence company standards development by participating as a Clinical SME for Quality initiatives.
  • Serves as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit.
  • Occasional domestic and international travel for meetings (less than 10%).


Required Qualifications:

  • Bachelor’s degree in healthcare/life science related field
  • 10+ years of work experience in related field
  • 7+ years of people leadership/management experience
  • 5+ Medical/technical/scientific writing experience
  • Budget management experience
  • Excellent communication and interpersonal skills

 

Preferred Qualifications:

  • Advanced degree (Master’s degree and above) in related area
  • Proven ability to work collaboratively and influence a broad range of global stakeholders
  • Demonstrated strategic perspective and ability to align activities with business vision and purpose
  • Relevant product and/or therapeutic knowledge/experience
  • Experience working with product development teams (e.g. Medical, Clinical, R&D, Regulatory, Design Quality Assurance)
  • Experience interacting with Regulatory Authorities or Notified Bodies
     

 

Requisition ID: 513098

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


Nearest Major Market: Boston

Job Segment: Risk Management, Manager, Medical, Law, Product Development, Finance, Management, Healthcare, Legal, Research

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