Role & Responsibilities
To accomplish this role, you will have the following responsibilities
Partner cross functionally with regional regulatory teams as well as Product Operations teams to develop and design programs in accordance with various regulatory requirements
Effectively manages the execution of the Regulated Materials process ensuring compliance to identified regulations/directives
Ensure products and parts are scoped appropriately
Partner cross functionally within the organization to drive conformance and compliance
Ensure the right support is given from/to other departments to accomplish the goals
Ensuring process compliance to applicable regulations, directives, and standards (e.g. PPWR, Batteries, WEEE, etc…)
Drive maturity of Extended Producer Responsibility Process
Continuously monitor compliance to applicable regulations/directives
In partnership with cross functional teams, define strategies to mitigate compliance issues.
Support business functions in creating a defensible, documented compliance package
Additional tasks may be assigned as needed
Experience
Minimum 5 years relevant experience
Data management, database creation, or data and information modeling
Deep understanding of product compliance regulations in regulated industry required
Ability to manage multiple objectives and priorities concurrently
Familiarity with key business applications such as SAP and Agile PLM
Exceptional knowledge of global Environmental Compliance Directives, Regulations and Standards including but not limited to: EU RoHS, Packaging, Battery, WEEE, REACH, Prop 65 and Conflict Minerals.
Experience analyzing compliance data to verify accuracy
Product, supply chain, and design control in a medical device manufacturer (such as BOM, COTS, Custom, ASL, AML, etc…)
Translating regulatory documents to extrapolate business requirements and or product requirements
Skills
In order to adequately perform the responsibilities of this position the individual must possess or demonstrate:
Exceptional organizational, data entry, decision making and analytical skills.
Excellent communication skills, both written and verbal.
Cross functional teamwork across all levels of the organization
Demonstrated self-starting, results driven, high energy level and ability to focus
Self-motivated and resourceful
Ability to manage multiple objectives and priorities concurrently
Excellent analytical skills, organizational skills, and verbal and written communication skills
Understands process flows and can think critically to develop options and recommendations
Proactive thinking and problem-solving skills
Ability to work independently with minimal supervision
Proven ability to communicate and collaborate with suppliers.
Strong collaborative, organizational and project management skills
Education
B.S. or higher in, Business Administration, Engineering, Regulatory Compliance, Chemistry, or equivalent work experience required.
Advanced degree preferred or equivalent experience
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
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
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.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
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 compensation ranges are listed.
