Manager II, Product Risk

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka

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.

**Please note that this role will be onsite in any Boston Scientific office location**

About the role:
The Senior Manager, Clinical Product Risk provides strategic, performance and people leadership for the Urology Product Risk team.  They have comprehensive leadership and technical skill sets and a thorough understanding of the relevant regulations and therapeutic areas as it relates to the clinical evaluation of medical devices.  They provide innovative solutions and drive cross-functional collaboration and strategic process improvement efforts. They are an SME and represent their function to internal and external cross-functional partners, while also leading, managing, and developing a high-performing team of Product Risk Specialists. They apply project management skills to maintain a complex array of clinical documentation for new submissions, acquisition integrations, and sustaining work. 
 

Your responsibilities will include:

• Provide strategic leadership and guidance for the Urology Product Risk team and divisional stakeholders for clinical evaluation strategy, planning, and execution of the CER and related documents (CEP, PMCF Plan, PMCF Evaluation Report, SSCP). Identify issues, develop and communicate proposed solutions to teams and senior management as required.
• Lead, manage and develop a high-performing team of Clinical Product Risk Specialists to generate CERs and related documents, to participate in new product development, sustaining, and acquisition integration core teams, to contribute to clinical regulatory and PMCF strategies, to respond to regulatory authority questions, and to contribute to quality processes related to post-market surveillance and risk management.  Foster a diverse workplace and create an inclusive culture that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Develop and maintain strong collaborative partnerships with key stakeholders in Design Quality Assurance, Regulatory Affairs, Medical Safety, R&D, PMO, PMCF, Medical Affairs, Clinical Operations, Biostatistics, and other functional groups to support new product development, sustaining activities, and acquisition integrations.  Engage all relevant stakeholders to ensure that Product Risk activities are aligned with broader portfolio decisions.
• Identify, propose and lead strategic process improvement initiatives that align with Product Risk, Clinical Science, and Urology divisional objectives and long-term vision. Establish project plans, milestones and outcome measures to define successful project achievement in collaboration with the Product Risk team and relevant stakeholders.   
• Apply technical expertise in EUMDR and global regulations and guidance of the clinical evaluation, post-market clinical follow-up, and post-market surveillance processes and strong collaborative skills to influence the development of global corporate SOPs and work instructions and divisional knowledge sharing documents.
• Apply technical expertise in EUMDR, ISO standards, and BSC quality processes to drive alignment of the clinical evaluation, risk management, and post-market surveillance processes through collaborative partnership with relevant stakeholders.
• Apply technical expertise of Urology medical devices and therapeutic areas to guide the development of safety and performance objectives, level of evidence requirements and equivalence strategies, and PMCF requirements to establish clinical evaluation strategies in partnership with relevant stakeholders. Provide strategic guidance on the clinical evaluation for acquired and OEM products.
• Serve as SME and functional representative in internal and external audits including audit participation, backroom support, preparing audit responses and supporting process improvements resulting from the audit.
• Manage complex cadence of clinical documentation to ensure documents and timing meet the requirements of BSC SOPs, project core teams, and regulatory agencies. Collaborate with functional manager on quarterly budget updates and annual budget planning. Contract and work with contractors and/or vendors to complete work as necessary

Required qualifications:

• Bachelor’s degree
• 7+ years of work experience in related field
• 4+ years of people leadership/management experience
• 4+ Medical/technical/scientific writing experience
• Excellent communication and interpersonal skills
• Proven ability to work collaboratively and influence a broad range of stakeholders
   

Preferred qualifications:

• Advanced degree (Master’s degree and above) in related area
• Demonstrated strategic perspective and ability to align activities with business vision and purpose
• Relevant medical device and/or therapeutic knowledge/experience in Urology
• Knowledge of the European Medical Device Regulation (EU MDR)
• Experience working with cross-functional project teams
• Experience interacting with Regulatory Authorities or Notified Bodies, including audit experience
   

Requisition ID: 564091

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.