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Sr Analyst - Post Market Surveillance

Expired Job

Illumina San Diego , CA 92140

Posted 5 months ago

Position Summary:

In accordance with Illumina's Quality Management System the Post Market Surveillance Analyst will be responsible for leading consolidated data reviews, identification and assignment of actions, and documentation of output from post-market surveillance meetings for specified Illumina products. The position will support regulatory compliance to U.S. and international regulations.

Key Responsibilities:

  • Fulfill the role of post-market surveillance product owner for specified Illumina products, including

  • Consultation with product development core teams on the creation of post-market surveillance plans for specified Illumina products.

  • Organize and lead post market surveillance data reviews after commercial product release with cross functional teams comprised of Quality, Medical Affairs, Regulatory Affairs, Product Marketing and other key stakeholders as required.

  • Coordinate analyses of post-market data with assigned data stream owners in the organization

  • Identification of key follow up activities from post market data review and assignment of follow up actions to the appropriate staff or teams.

  • Documentation and routing of post-market surveillance meeting output in accordance with Illumina's QMS procedures.

  • Participate in regulatory audits/internal audits and inspections as appropriate to represent and defend the post-market surveillance plans and output for specified products.

  • Other projects and responsibilities as assigned.

  • Support systems and data streams for the receipt and recording of Customer Complaints.

  • Support the evaluation of complaints through responsible Quality and Regulatory department/divisions.

  • Support preparation for and representation of the Department for internal/external regulatory audits.

  • Proactively identify system and process improvement to ensure the department maintains current regulations with a high degree of efficiency.

The position will report to the Associate Director, Post Market Surveillance.

Skills & Capabilities:

  • Strong ability to derive data from enterprise systems, data analysis and trending skillsets

  • Strong Illumina internal network or demonstrated ability to build strong internal networks

  • Strong analytical, project management skills, and presentation skills

  • Effective verbal and written communication in individual and group settings

  • Must be detail oriented, have good organizational skills and be able to meet deadlines.

Min Knowledge & Experience required for the position:

  • Requires a Bachelor degree, preferably in biology, molecular biology, science or regulatory related areas

  • Minimum of 5 years' experience in the medical device industry (in vitro diagnostics a plus)

  • Good working understanding of Illumina technology

  • General understanding of the molecular diagnostics market in Oncology, Reproductive Health, Genetic Health

  • Experience with Post Market Surveillance Requirements.

  • Familiarity with FDA 21 CFR 820, ISO standards, IVD Directive/Regulation and ISO 13485.

  • Language fluency: English, with additional languages a plus

International Mobility:

Required: no

Travel requirements:

< 5%

illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. if you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. to learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf 5%="" illumina="" believes="" that="" everyone="" has="" the="" ability="" to="" make="" an="" impact,="" and="" we="" are="" proud="" to="" be="" an="" equal="" opportunity="" employer="" committed="" to="" providing="" employment="" opportunity="" regardless="" of="" sex,="" race,="" creed,="" color,="" gender,="" religion,="" marital="" status,="" domestic="" partner="" status,="" age,="" national="" origin="" or="" ancestry,="" physical="" or="" mental="" disability,="" medical="" condition,="" sexual="" orientation,="" pregnancy,="" military="" or="" veteran="" status,="" citizenship="" status,="" and="" genetic="" information.="" if="" you="" have="" a="" disability="" or="" special="" need="" that="" requires="" accommodation,="" please="" contact="" us="" at="" applications@illumina.com.="" to="" learn="" more,="" visit:="">

illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. if you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. to learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf>


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Sr Analyst - Post Market Surveillance

Expired Job

Illumina