Senior Manager Product Compliance
Senior Manager Product Compliance
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position:
Senior Manager Product Compliance and Escalations will provide oversight expertise and support to ensure on-going compliance with domestic and international regulations and standards. S/he will work with cross functional organizations (Quality Systems Product Quality Risk Management Clinical Post Market Service Customer support etc.) as the Compliance representative and support product issues/escalations triaging the issues review of product investigations understanding impact to the field and oversee any associated field corrections and removals. S/he will ensure overall Quality Management System (QMS) compliance to internal process/procedures as well as regulatory requirements/standards and ensure understanding of applicable laws and regulations so that the companys risks are identified and managed appropriately.
Roles & Responsibilities:
- Compliance representative on escalation meetings to understand the product/process issue risk clinical impact and help establish escalation decisions/conclusions.
- Support Product Investigations help with determination of field impact and any associated field actions corrections and/or removals.
- Oversee field action strategy execution and implementation based on understanding of product technical issue clinical/product/user risk and actions to be taken with the product in the field.
- Help author and review field action and customer letters/communication to ensure the documentation aligns with the overall strategy and meets the regulatory/compliance requirements.
- Help author and review any follow-up questions responses related to the field actions.
- Help provide guidance on a variety of ad-hoc product/compliance questions including helping research the regulations current process/practices within ISI industry/regulatory agency expectations etc.
- Provide guidance review and approve various documents on behalf of Reg. Compliance ranging from EDFs PIRs customer facing materials technical bulletins QS procedures.
- Participate in process improvements streamlining and scalability associated with above processes.
- Proactively identify and anticipate risk of non-compliance in a dynamic environment conformance to regulatory requirements internal processes and policies.
- Support the Quality System and Compliance (QSC) team overall as needed related to QRB/Management Review Audits Facility Changes CAPAs Process improvements etc.
Qualifications :
Skills Experience Education & Training:
- 10 years of experience in a Quality role in the medical device industry is required.
- 4 years experience as a people lead/manager
- Bachelors Degree in an engineering scientific or other relevant field is required. Masters Degree in engineering or scientific field preferred.
- Demonstrated ability to understand complex technical issues and direct experience working with surgical medical devices/instrumentation (US: Class II and III) in (any) area of Capital Equipment Software Wireless technology Disposable/Reusable instrumentation and/or implantable devices
- Demonstrated experience/exposure to aspects of Medical Device Design Control and/or Production/Process Controls and/or Corrective/Preventive Actions and/or Corrections/Removals
- Demonstrated ability to work in highly cross-functional teams including direct experience working with engineering clinical and risk management functions.
- Demonstrated ability to effectively manage teams/direct reports provide guidance make decisions and manage growth
- Applied understanding of US FDA Quality System Regulations ISO 13485 ISO 14971
- Ability to be a team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use risk based judgment.
- Critical thinking skills and a passion to work in a fast paced industry with complex/cutting edge technology
- Strong organizational written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
