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Form of workJOB SUMMARY:
The Sr. R&D Specialist will work with internal business partners and product development teams to provide technical support for biocompatibility processes. This position ensures product safety and leads risk mitigation efforts. This role is responsible for the conduct of biological evaluations, develop biocompatibility strategy, and review biocompatibility test protocols/reports. This position plays a critical role in product development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization.
MAJOR RESPONSIBILITIES:
Support and consult internal business partners related to biocompatibility issues and challenges to resolve.
Authors, review, and approve Biocompatibility strategy, test protocols/reports, and Biological risk assessments for regulatory compliance
Evaluates and summarizes biocompatibility and general toxicology data to assess the biological risks
Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993 and ISO 14971, for submissions to FDA and other regulatory agencies.
Maintain and evolve quality system documentation and procedures relevant to toxicological and biological risk assessment
Perform biocompatibility gap analysis and write clear concise report
Support biocompatibility, extractable/leachable, or in-vivo safety testing required in support of a product claim
Compile risk assessments, identify gaps, and propose solutions.
Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards
Qualifications - External
COVID-19 Vaccination
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
Bachelor's degree in Chemistry, Biology, or related science field
Work Experience
- A least 4 years of experience in a medical device or pharmaceutical related field.
Knowledge / Skills / Abilities
- Knowledge of FDA requirements and experience with FDA interactions as part of the 510k processes.
- Knowledge of CE technical files.
- Experience with risk assessment and root cause analysis.
- Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
- Experience communicating with internal and external business partners and cross functional teams with various audiences.
- Experience in project management skills, with ability and proven track record to plan, manage and develop strategic initiatives to successful goal completion.
- Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
- Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.
- Ability to influence and motivate others to drive results in a multi-location and matrixed environment.
- Position may require travel up to 10% of the time for business purposes (domestic and international).
Education
- Bachelor's degree in Chemistry, Biology or related science field.
Work Experience
- A least 4 years of experience in a medical device or pharmaceutical related field.
Knowledge / Skills / Abilities
- Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.
- Knowledge of CE technical files.
- Experience with risk assessment and root cause analysis.
- Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
- Experience communicating with internal and external business partners and cross functional teams with various audiences.
- Experience in project management skills, with ability and proven track record to plan, manage and develop strategic initiatives to successful goal completion.
- Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
- Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.
- Ability to influence and motivate others to drive results in a multi-location and matrixed environment.
- Position may require travel up to 10% of the time for business purposes (domestic and international).
