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.
RESPONSIBILITIES:
- Ensure compliance with local regulatory requirements/legislation and embecta Regulatory Affairs policies and procedures including special licenses/certifications.
- Suggest and implement regulatory strategic and tactical plans for new products, product changes, and complex regulatory issues in alignment with company priorities.
- Monitor the local regulatory environment and regulatory publications to anticipate strategies and communicate to the LATAM Sr Manager. Assess and communicate any update needed in the QMS for Colombia.
- Develop and submit local regulatory applications for new registrations, product changes and renewals in a timely manner to ensure business growth and continuity.
- Obtain and maintain records, registrations and notifications for products regulated by the Health Authorities and communicate to the function and business.
- If needed, keep interactions/negotiations with INVIMA and support distributor that hold registrations in the Andean and Southern Cone regions.
- Support Adverse event reporting and vigilance follow up to regulatory agencies.
- Support overseeing Field Action activities in the Andean and Southern cone region.
- Support post-market surveillance reports according to regulatory requirements of the countries in the Andean and Southern cone region.
- Support the generation of metrics, reports and basic presentations of the Regulatory Compliance processes to contribute to managerial decision making.
- Support regulatory audits and inspections.
- Support review and approval of local labeling, advertising and promotion to ensure compliance with local regulatory requirements.
- Support the regulatory needs of external customers and/or tenders within the Andean and Southern cone region.
EXPERIENCE & EDUCATION:
- Desired academic background: University Graduate in Engineering, Pharmacy, Biology, Medicine, and/or Biochemistry. Experience as technical director.
- Desired work experience: 5-7 years in similar positions with experience in Health Product/Medical Device Industries.
- Language level: Advanced English and native Spanish
KNOWLEDGE, SKILLS AND ABILITIES:
- Communication
- Teamwork
- Influencing others
- Decision making
- Planning, Coordination & Execution
- Customer service 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.