Chief Risk Officer jobs

Your responsibilities will include:

• Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.)
• Collaborate with cross-functional partners to support clinical risk analysis and enhance documentation quality
• Conduct and analyze literature searches to interpret and summarize harms, hazards, alternative therapies, and device-specific benefits for risk assessment
• Identify the need for and generate clinical risk-related documents for commercial or in-development products to meet both internal and external regulatory requirements
• Act as a liaison between the Clinical Product Risk function and cross-functional project teams, ensuring effective communication of relevant information
• Collaborate with Clinical and R&D functions to develop consistent clinical deliverable criteria and rationalize the need (or absence) of clinical trials
• Serve as a mentor and subject matter expert in clinical product risk activities; provide consulting support on complex projects and product grouping strategies
• Represent the function as a product SME during audits (FDA, Notified Body, and internal), including preparation of documentation and CAPA responses

Required qualifications:

• A bachelor’s degree and minimum of 3 years' experience in life sciences, engineering, or a related field
• Or minimum of 7 years' experience in the respective field without a degree
• Medical and/or technical writing experience

Preferred qualifications:

• Experience in the medical device industry
• Knowledge of therapeutic areas and device classifications
• Strong ability to collaborate cross-functionally and at all organizational levels
• Proven skills in interpreting and synthesizing clinical and commercial data
• Excellent attention to detail and strong organizational skills
• Solid understanding of business procedures, quality systems, and regulatory compliance

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Spencer Gregory Hale

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

• Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
• Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
• Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
• Supporting internal and external audits and audit responses for existing products.
• Monitoring compliance with company policies and procedures.
• Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

• Bachelor's degree in Science, Health, or Engineering.
• Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
• Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

• Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
• Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
• Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

• Produce and maintain Clinical Evaluation Reports (CERs) for the global product portfolio in accordance with company SOPs and applicable regional regulations (e.g., FDA 510(k)/PMA, EU MDR, Health Canada, PMDA, etc.). Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis
• Analyze literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
• Identifies the need for and/or generates clinical risk related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
• Serves as a liaison between Clinical Product Risk function and project team. Clearly communicates pertinent project/function information.
• 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.
• Mentors and serves as subject matter expert in key clinical product risk activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
• Serve as product SME during FDA, Notified Body, and internal audits; prepare back‑room documentation and CAPA responses.

• A bachelor’s degree and 5+ years of professional experience in life sciences, engineering, or related field.
• Or 10+ years of professional experience in the respective field.
• Medical and/or technical writing experience required

• Medical Device industry experience preferred
• Therapeutic area knowledge desired
• Ability to work cross-functionally at all levels of organization
• Proven ability to analyze, interpret and synthesize clinical and commercial data
• Attention to detail and strong organizational skills.
• Understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment and failure to adequately perform tasks can result in noncompliance with governmental regulations.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.