Manager, Global Toxicology and Biocompatibility

Boston Scientific; Arden Hills (MN); Hybrid; USD 107,000 - 203,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Manager of Global Toxicology and Biocompatibility to lead the development of toxicology and biocompatibility processes supporting medical device products. You will guide regulatory submissions, coordinate internal teams, and manage external labs, ensuring patient safety and product quality.

The role follows a hybrid work model, with in-office presence required at least three days per week, and relocation is not offered.

Qualifications

• Bachelor’s degree in a chemistry/biochemistry/biology/biomedical engineering/toxicology or related field.
• 8+ years of professional toxicology/biocompatibility experience, or 6+ years with an advanced degree.
• 2+ years leading technical staff or projects.
• Deep understanding of biocompatibility of medical devices and ISO 10993.
• Experience interacting with regulatory authorities and submitting products.

Responsibilities

• Provide strategic leadership on the Global Toxicology and Biocompatibility process.
• Assist in setting objectives and influencing procedures for biocompatibility programs.
• Serve as key resource for biocompatibility and toxicology for devices and pharma products.
• Supervise staff coordinating testing with external labs and assessing data.
• Provide regulatory guidance for medical device submissions globally.
• Develop relationships with R&D, regulatory, quality, and manufacturing teams.
• Ensure data accuracy and support business objectives.
• Liaise with external CROs for testing.
• Commit to patient safety and product quality in all decisions.

Skills

Excellent written and verbal comms

Regulatory experience

Leadership of technical staff

ISO 10993 biocompatibility knowledge

8+ years toxicology/biocompatibility

Education

Bachelor’s degree in chemistry/biochemistry/biology/biomedical engineering/toxicology or related field

Advanced degree in related field (preferred)

Job description

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 and synergy. This role follows a hybrid work 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 by providing a 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, neurological and urological diseases and conditions. Learn more atwww.bostonscientific.comand follow us onLinkedIn.

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 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.