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.
Description
- Develop best-in-class submission strategy.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Negotiate and interact with PMDA and MHLW during the development and review process to ensure submission approval.
- Build positive relationships with authorities.
- Monitor and submit applicable reports and responses to regulatory authorities.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders.
- Provide regulatory input for and appropriate follow-up to inspections and audits.
- Provide regulatory input for product recalls and recall communications.
- Review and assess external documents/communications relative to regulations.
- Strategize with and advise internal stakeholders on regulatory issues and requirements.
- Provide training for stakeholders on regulatory requirements including safety related operations to ensure company-wide compliance.
- Execute activities required by Safety Controller by law.
- Establish and maintain procedures per QMS and GVP ordinances.
- Operate a series of processes to handle complaints, complaint captures - decision for safety remediation actions, feedback to customers.
- Approve and execute safety remediation action.
- If required, attend meetings of the industrial activities and express the opinions of embecta.
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.
What We Do
At embecta (formerly part of BD) we are a global medical technology company singularly focused on improving the lives of people living with diabetes. For nearly 100 years, we’ve been developing and providing solutions to the diabetes community. We are the leaders in insulin delivery, with more than 30 million people in over 100 countries relying on our pen needle and syringe products.
BD is the manufacturer of the advertised products.
Privacy Policy: https://www.embecta.com/en-us/about/policies/privacy-policy-statement