Description

Paragon 28’s growth continues and we’re looking for more great employees! Now is your chance to join this public company dedicated to improving a patient’s quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Sr. Scientist - Toxicology & Biocompatibility with a starting range of $120,000 - $145,000/year, dependent upon experience, education, and skills. This position requires a full-time onsite presence.

The Sr. Scientist Toxicology and Biocompatibility is responsible for evaluating and evidencing the safety of orthopedic implants and instruments. This includes the evaluation of the raw material, the manufacturing processes used to fabricate and clean the device, and the clinical history of application. This is an individual contributor role.

Key Responsibilities

• Implement end to end, state-of-the-art approaches to biological evaluation within an evolving regulatory environment
• Conduct Biological Safety Risk Assessments on orthopedic devices in accordance with ISO 10993 and EU MDR requirements
• Coordinate and manage biocompatibility and chemical characterization studies with 3^rd party vendors that comply with industry standards (ASTM, ISO)
• Define testing strategies for materials, designs, and processes that satisfy cost and technical requirements
• Write toxicological risk assessments and biological evaluation reports
• Preparation of responses to inquiries from regulatory agencies (ex. FDA, BSI, CFDA, PMDA.) in a timely and thorough manner
• Work collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
• Maintain competency in applicable standards (ISO, ASTM) which affect orthopedic medical devices
• Proactively identify future biological safety challenges and develop strategies to address them
• Review/assess test protocols and test reports to evaluate biological risks as they relate to processing of medical devices
• Review, prepare, and maintain biological evaluation and cleaning procedures to keep pace with standards development
• Maintain and review supplier chemical contact lists
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
• Maintain relevant scientific and medical knowledge by attending conferences, courses and meetings
• Help to develop and generate material for staff training and data presentations
• Lead biological safety initiatives for CAPAs, HHEs, complaints/field actions providing biological safety expertise when required
• Provide support for key opinion leaders
• Other duties as assigned.

Work Environment
This job operates in a professional office environment, as well as being performed in a distribution/warehouse environment.

Position Type/Expected Hours of Work

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.

Travel

Travel should not exceed 10% of total time. Supplier travel might be needed for on-site trouble shooting and or audits.

Qualifications

• MS degree in Toxicology (or related field) required; PhD degree preferred or bachelor’s degree with 5 years relevant experience
  1. DABT certification a plus
• Familiarity with ISO 10993 family of standards
• Familiarity with material (ASTM) and other medical device standards (ASTM, ISO) preferred
• Technical writing skills that include studies and reports
• EU MDR experience preferable
• Effective communication and presentation skills with ability to convey complex information to lay audience. 
• Ability to follow standard operating procedures
• Ability to work independently and with cross functional groups
• Ability to manage time well with multiple tasks and to prioritize short notice deadlines with regular assignments.
• Demonstrated computer proficiency in Microsoft Suite products.

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010, every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services. Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more. Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program. A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate. You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.

Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.