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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do-
- Coordinate the annual submission plan for new product registrations and renewals, aligning plans with COFEPRIS requirements and contributing to their development. Also, responsible for handling specific or challenging demands.
- Lead and manage a team of three individuals overseeing medical equipment regulatory submissions to COFEPRIS in Mexico.
- Conduct monthly meetings with AMID and engage with regulatory affairs counterparts in other Latin American countries, the US, and production facilities.
- Oversee the regulatory submission process for medical devices, ensuring compliance with COFEPRIS guidelines and maintaining contact with manufacturing plants.
- Collaborate cross-functionally to align regulatory strategies with product development and commercial goals, ensuring adherence to regulatory standards.
- Participate in the creation and enhancement of regulatory submission plans, adapting to evolving regulatory requirements.
- Supervise, guide, and provide direction to the regulatory affairs team, ensuring their professional growth and development.
- Maintain a comprehensive understanding of medical device regulatory standards and updates, applying them to enhance registration processes and submissions.
What you will need-
- Previous experience in similar positions, working in Medical Devices companies, required.
- Bachelor’s Degree required.
- Advanced English skills required.
- Previous experience in management positions required.
- Participation in COFEPRIS associations required.
- Azure DevOps (ADO) and Power BI expertise desired.
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.
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