Product Risk Manager - Global Safety

Job Description: Are you an innovator looking for a new challenge? Join us! Boston Scientific, a leader in less-invasive medical technologies, is growing - and looking for your expertise. We are currently searching for a Therapeutic Product Risk Manager to join our Global Safety Office within Clinical Research. This position is located in Marlborough, MA, but may have flexibility to be located in our Maple Grove, MN or Fremont, CA locations.

General Summary:
Under limited supervision, the Therapeutic Product Risk Manager coordinates the deliverables of clinical risk/benefit analyses in a therapeutic area by collaboration with medical, legal, other cross functional and cross-divisional professionals to ensure that the risks associated with the use of the medical device are effectively managed.

The Therapeutic Product Risk Manager using confidential company data ensures that product risk management activities are conducted in accordance with Regulatory and company standards in meeting schedules and performance requirements and will be involved in process development, staff and cross functional/divisional training, and resource and budget assessment. This individual interacts with a variety of internal and external stakeholders and may directly supervise staff.


Duties and Responsibilities:


May provide some functional management oversight for the Product Risk Analysis group and/or external consultants.

Provide collaborative support to Product Support (Hybrid Partnership) on deliverables required to coordinate the completion of the Clinical Risk/Benefit Analysis (CRBA).

Identifies projects (scheduling) and number of required resources to forecast a budget for Clinical and Business Unit management.

Tracks the project timeline and the associated deliverables via a status update to the Clinical and Business Unit management.

Leads and/or coordinates the development and/or updating of the CRBA with cross functional and cross divisional inputs through an approval process.

Acts as a liaison between Clinical management in support of PDP projects and Quality and Regulatory partners to obtain necessary information for CRBA preparation providing a returned deliverable to either Core Team or Regulatory for needed submissions or responses to questions from notified bodies.

Creates and maintains CRBA-related documentation for audit readiness.

Develops and maintains necessary procedures or work instructions or participates in process improvement initiatives, as needed.

Interfaces with Legal to develop and/or maintain vendor contracts.


Position Qualifications:
Minimum Education and Experience:

A degree in science or a health-related professional standing is preferred. Eight plus years experience in clinical/scientific research understanding principles of medical device and/or pharmaceutical and/or combination product processes. At least four years experience in managing projects and working in a cross-functional product development setting required. Experience performing scientific literature reviews, preferred.

Working Conditions:

General office environment. May include approximately 20% travel to meetings and/or other BSC facilities.

Competency Expectations:


Able to develop effective and productive working relationships and maintain interface with medical, clinical, legal, other cross-functional and cross-divisional professionals and external consultants, as needed.

Demonstrate evidence of excellent verbal and written communication skills at all personnel levels.

Demonstrated evidence of excellent computer skills, e.g., word processing or some electronic document management system.

Able to understand and process complex scientific, medical and technical information including leveraging expertise and knowledge across projects.

Demonstrated experience within a clinically therapeutic area and working knowledge of human anatomy, physiology, and medical terminology.

Has familiarity with ISO 14971 composition & minimum requirements or know the difference between a Design Dossier (DD) and a Technical File (TF).

Served with cross functional partners in the exercise of developing a Use and Design Failure Modes and Effects Analysis (FMEA) workbook or equivalent.

Demonstrated flexibility and ability to manage multiple, complex projects with changing timelines taking ownership and working independently.

Searchable Keywords: Therapeutic Product Risk Manager / gj-mo

Minimum Education Required: Bachelor

Years of Experience Required: At Least 3 Years

Expected Travel Time: About 25%

This company may offer relocation assistance.


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.