Embecta
Senior Regulatory Affairs Specialist
Company
Role
Senior Regulatory Affairs Specialist
Location
Mexico
Job type
Full-time
Found on Mokaru
3 days ago
Salary
Job description
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.
Why join us?
A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.
At embecta, we are committed to advancing care and improving lives. As a Senior Regulatory Affairs Specialist, you will play a critical role in bringing innovative medical devices to market across Mexico. This is a high-impact role, partnering with heath authorities and directly contribute to the business growth.
This role is hybrid on-site two days a week at our Mexico City office
What You'll Do:
As a trusted regulatory partner, you will:
- Lead end-to-end regulatory activities for new product registrations, renewals, and product changes.
- Develop and execute regulatory strategies aligned to business priorities
- Ensure compliance with local regulatory requirements and embecta policies
- Manage the lifecycle of product registrations, including working with distributors and third-party partners.
- Act as a key liaison with health authorities and industry associations in Mexico.
- Support post-market surveillance, vigilance reporting, and audit readiness
- Provide regulatory risk assessments and strategic recommendations to internal stakeholders
- Review and approve labeling, promotional materials and advertising for compliance.
- Monitor the evolving regulatory landscape and proactively influence outcomes
What you Bring
- University Degree in Engineering, Pharmacy, Biology, or related field
- Minimum of 5 years experience of Regulatory Affairs experience within medical devices/healthcare industries.
- Advanced English (written and verbal) and native Spanish fluency
- Strong communication and stakeholder influencing skills
- Ability to plan, prioritize, and execute in a fast-paced environment
- Strategic thinking and regulatory problem-solving
- Collaborate mindset with a customer-focused approach
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
