Staff Compliance Engineer

Staff Compliance Engineer

Vacancy expired!

job summary:

Company Description


A technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures .




location: REDWOOD CITY, California

job type: Contract

salary: $70 - 75 per hour

work hours: 8am to 4pm

education: Bachelors



responsibilities:

POSITION SUMMARY


Review and monitor required corrective actions; conduct follow-up activities on required action items.


Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.


Providing support for FDA, Health Authority and Notified Body inspections conducted at RAD sites, including readiness activities, front- and back-room participation/management and general inspection support as requested. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.


Consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.


Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.


Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the RAD portfolio.


Partner with stakeholders and business partners to assess risk and establish proactive risk mitigation strategies and enable innovation in emerging areas.


Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as safety and environmental policy and procedures.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES


1. Support ERC/IA/External QSR/GMP/ISO quality system audits and follow-up activities. (25%)


2. Assists project teams with identification of quality system requirements to ensure compliance. (25%)


3. Inspection Readiness (10%)


4. Monitors regulatory agencies for changes in requirements and evaluates impact to the organization. (20%)


5. Performs other related duties as assigned by management. (20%)

QUALIFICATIONS


Minimum education required for competent performance:


Bachelor's Degree - Scientific Discipline or equivalent (RAC certification, ASQ - CQA, CQE or SCQE, ISO Lead Assessor).


Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

• Minimum of 4 years of working experience in the quality assurance / compliance environment. communication, organizational, negotiation and interpersonal skills.
• Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n16; CMDR - SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH Google Cloud Platform Guidelines, MDSAP, etc.)
• Knowledge of IT internal controls, software development lifecycle (SDLC) methodologies, data integrity requirements, as well as general knowledge of cybersecurity and Medical Device software is a preferred skill.

qualifications:

• Experience level: Experienced
• Minimum 5 years of experience
• Education: Bachelors (required)

skills:

• Med Device
• SOP
• MDSAP
• MDR

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.



Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.



We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.