- San Jose, CA, 94088, US
- Remote-US
- United States of America-Arizona-Phoenix
- United States of America-Texas-Flower Mound
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Job description
Stryker is hiring a Regulatory Operations Project Manager, Product Environmental Compliance. This position is Remote, supporting our Endoscopy Division. Preference will be given to candidates in the Western and Central locations of the United States.
What you will do
Serve as a technical leader for the Regulatory Affairs organization, with focus on product environmental compliance projects across the Regulatory Operations function.
- Leads regulatory strategy and technical pathways for cross functional and potentially cross divisional projects which serve to improve quality compliance and reduce regulatory risk related to product environmental compliance.
- Raise awareness, assess and determine strategy for application of changing or new global regulations.
- Stay abreast of upcoming changes and advise management on risks, impact and likely project needs for regulation changes.
- Leads others in application of understanding of industry practice, domestic and international regulations and company policies to effectively implement and improve product quality and the quality management system.
- Manages process for product environmental compliance including serving as SME in Regulatory, internal and external audits.
- Lead multiple business units in development of processes/procedures for and implementation of new or revised regulatory requirements.
- Set direction and strategy for regulatory affairs organization and department projects.
- Interface with data focused organizations to drive data availability, integrity and trending as necessary for product environmental compliance.
- Lead projects that aim to drive continuous improvement in processes, procedures or work of RA or divisional teams.
- May own, review and approve non-conformances and planned deviations, review and analyze data for trending purposes.
What you need
- Bachelor’s degree in a relevant field such as life sciences, biologics and/or pharmaceutical field required.
- A minimum of 8+ years of work experience required .
- 2-4 years experience in medical device with Bachelors or 1 year of experience with Masters degree, biologics and/or pharmaceutical field desired.
- Knowledge of applicable international regulations and standards (RoHS, REACH, etc.)
Preferred
- Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry)etc.
- PMP or related certification.
- Regulatory Affairs Certification.
- Lead development of process and product protocols and reports.
- Lead development of statistical process controls and analyzing data.
$113,900.00 - $186,700.00 USD annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness
insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and
tobacco cessation program.
Financial benefits include:Health Savings Account (HSA), Flexible Spending Accounts (FSAs),
401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient
and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients
annually. Depending on customer requirements employees and new hires in sales and field roles that require access to
customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of
their role.