Manager, Global Toxicology and Biocompatibility

Boston Scientific Gruppe; Marlborough (MA); On-site; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific Marlborough, MA seeks a Manager, Global Toxicology and Biocompatibility to lead development of robust processes ensuring patient safety across global regulatory submissions. The role oversees staff, interfaces with R&D, regulatory, quality engineering and manufacturing, and coordinates testing with external labs.

Hybrid work model with in-office presence at least three days per week. Minimum salary range is listed; relocation not available; visa sponsorship not offered.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field.
• Minimum of 8 years of professional toxicology/biocompatibility experience, or 6+ years with an advanced degree.
• Minimum of 2 years of leadership experience of technical staff.
• Strong understanding of biocompatibility of medical devices and ISO 10993.
• Excellent written and verbal communication skills.
• Experience working with regulatory authorities.

Responsibilities

• Provide strategic leadership and guidance on the Global Toxicology and Biocompatibility process.
• Assist leadership in setting objectives and influencing procedures and approaches at divisional levels.
• Serve as a key resource for biocompatibility and toxicology expertise for devices and products.
• Supervise staff coordinating biocompatibility testing with external labs and assess data.
• Provide regulatory guidance for medical device submissions globally.
• Develop relationships with R&D, regulatory, quality engineering, and manufacturing.
• Ensure data is accurate, reliable, and supports business objectives.
• Develop testing strategies, coordinate external testing, and author Biocompatibility Reports.
• Act as liaison to external Contract Research Organizations for testing.
• Demonstrate commitment to patient safety and product quality.

Skills

Leadership experience

Regulatory experience

Communication skills

Education

Bachelor's degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field

Advanced degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field

Job description

Manager, Global Toxicology and Biocompatibility

Onsite Location(s): Marlborough, MA, US, 01752

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

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:

Global Toxicology and Biocompatibility plays a critical role in medical device development at Boston Scientific, ensuring patient safety while enabling early product development decisions, supporting product design direction, enabling product approvals, and supporting market launch for product commercialization.

The Manager, Global Toxicology and Biocompatibility, provides technical leadership and support for the development of robust toxicology and biocompatibility processes to meet global business objectives. As the Manager, this position is responsible for ensuring processes and staff support the overall biological evaluation of medical device products. This includes support for new product development and sustaining activities, as well as global regulatory submissions, including related technical support to staff and project teams to meet business objectives. This role will interface with internal stakeholders to plan, resource, and execute biocompatibility deliverables to support divisional and operational priorities.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

At Boston Scientific, we value collaboration andsynergy. This role follows ahybridwork model, requiring employees to be in our local office at least three (3) days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Provide strategic leadership and guidance on the Global Toxicology and Biocompatibility process
• Assist the Associate Director in setting Global Toxicology and Biocompatibility business objectives, influencing procedures, techniques, concepts, and approaches used at divisional levels for biocompatibility and toxicology programs
• Serve as a key resource for biocompatibility and toxicology expertise for medical devices and pharmaceutical products for the Global Toxicology and Biocompatibility organization and assigned business divisions
• Supervise scientific staff responsible for coordinating recommended biocompatibility testing with external research labs and assessing applicable test data
• Provide strategic guidance and interpretation of regulatory requirements related to medical device submissions for the global organization and assigned business divisions
• Develop close working relationships with R&D, regulatory affairs, quality engineering, and manufacturing, maintaining close communications with internal customers on biocompatibility and toxicology related deliverables
• Ensure biocompatibility and toxicology information and data is accurate, reliable, and supports business objectives
• May develop testing strategies, coordinate and monitor testing with external research labs, assess data, and author/review Biocompatibility Assessments and Reports for assigned business divisions
• Act as a key liaison to external Contract Research Organizations for biocompatibility and toxicology testing
• At the basis of every decision, demonstrate a primary commitment to patient safety and product quality

Required qualifications:

• Bachelor’s degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field
• Minimum of 8 years of professional toxicology/biocompatibility experience, or minimum of 6 years of professional toxicology/biocompatibility experience with an advanced degree
• Minimum of 2 years of professional experience as a leader of technical people (not necessarily by means of direct reports)
• Complete understanding and wide application of principles, theories, and concepts in the biocompatibility of medical devices, including demonstrated expertise with ISO 10993
• Excellent written and verbal communication skills
• Experience working with regulatory authorities

Preferred qualifications:

• Advanced degree in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field
• Prior experience in medical device and/or pharmaceuticals
• Comfortable in a dynamic environment and able to work independently as well as on teams
• Results-oriented and detail-oriented, able to multi-task while working within aggressive timelines
• Proven leadership and management of a technical group, providing coaching and development
• Applied knowledge and understanding of toxicology principles and best practices
• Working knowledge of quantitative toxicological risk assessment methodologies

Requisition ID:632935

Minimum Salary:$106800

Maximum Salary: $202900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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 specificprohibited substancetest 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.

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