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Clinical Product Risk Manager I

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.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s):  N/A

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 this role:
The Clinical Product Risk Manager I has a comprehensive skill set and thorough understanding of multiple therapeutic areas as they relate to medical devices and develops global evidence-based clinical strategies for the Rhythm Management Division by collaborating with management, a small team, and cross-functional partners. They provide innovative solutions and lead resolution of cross-functional issues and process improvement efforts. They are an SME and represent their function to internal and external cross-functional partners, while also training junior level specialists. A successful candidate has excellent oral and written communication skills as well as the ability to work collaboratively. Leadership in this role supports product approval, indication expansion and claims support, and mandated post-market requirements.
 
Your responsibilities will include: 

  • Execute, lead and train others on all aspects of Clinical Evaluation Report (CER) research, analysis, interpretation and document generation.  Identify issues, develop and communicate proposed solutions to teams and senior management as required.
  • Independently utilize understanding of therapeutic area to identify and interpret information impacting clinical evidence and risk management by mentoring individual contributors in evaluating scientific literature and publications, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data and staying abreast of current clinical practice.
  • Lead junior staff through process to author clinical evaluations and ensure team creates relevant clinical documentation in support of related clinical evaluation deliverables to comply with applicable clinical and regulatory standards.
  • 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 Clinical 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 as applicable.  Collaborates with functional manager or director on quarterly budget issues.
  • Work with contractors and/or vendors to complete work as necessary and ensure compliance to training, corporate standards and regulatory agencies.
  • Lead post-market clinical follow up (PMCF) workstreams with internal cross-functional teams to ensure data and reporting are timely and meet EU MDR requirements. Develop process improvements for PMCF and associated value improvement projects.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for clinical evidence plans related to CER and MEDDEV/MDR compliance 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.
     

Required qualifications:

  • Bachelor’s degree with a scientific focus
  • A minimum of 7 years of related work experience or an equivalent combination of education and work experience.
  • Medical/Technical writing experience

 

Preferred qualifications:

  • Electrophysiology (EP) and/or Cardiac Rhythm Management (CRM) Clinical Risk/Safety/Trial experience 
  • Advanced degree (Ph.D. or other)
  • Excellent communication skills (written and verbal).
  • Ability to use in-depth knowledge of business unit functions and cross group dependencies/relationships.
  • Strongly prefer a professional with a wide-range of experience and expertise in a specialized technical field.

 

Requisition ID: 542202

 

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.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


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