|Title:||Regulatory Affairs Manager|
|Job Location:||Earth City, MO|
Young Innovations is a manufacturer and marketer of high quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
We are looking for a strong Regulatory Affairs Manager who is a self-motivated, highly confident, and results-oriented professional to join the Young Dental. The Regulatory Affairs Manager will be responsible for supporting corporate-wide global initiatives to establish and maintain submission plans and associated timelines, and represent Young Innovations operations from a Regulatory perspective.
- Direct the coordination of corporate-wide Regulatory Affairs activities for Medical Devices and Drugs.
- Develop and execute regulatory plans for projects, including new products and maintenance of licenses/authorizations for existing products.
- Manage successful submissions for new marketing authorizations, renewals, variations and line extensions for the USA and International regions (LATAM, MEA, APAC, CIS) and drive the approval process.
- Manage domestic and international registrations, listings, ISO certifications, and in-country product registrations.
- Monitor applicable regulatory requirements; assure compliance with Young Innovations’ internal requirements and external standards.
- Create technical files and clinical evaluation reports for products distributed in Europe.
- Ensure that changes are documented in accordance with internal procedures and are communicated in a timely manner to the Health Authorities.
- Represent the RA function on assigned cross-functional project teams.
- Establish appropriate communication within other functions primarily at project level.
- Ensure project teams, business objectives, and deliverables are aligned with regulatory strategy.
- Perform gap analysis and propose solutions to maintain compliance to internal and external regulatory requirements.
- Develop and document sound regulatory decisions and justifications.
- Review promotional material or SOPs for compliance with local and global regulations.
- A Bachelor of Science degree in a related field, supplemented by at least 7 years of relevant experience with 2 years in a leadership role with a demonstrated pattern of success
- Strong knowledge of Regulatory as it relates to Medical Devices and Drugs
- Excellent Technical and Clinical writing skills and ability to conduct Clinical Research using medical literature and online tools.
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication skills and presentation skills
- Ability to independently identify compliance risks and escalate when necessary
Young Innovations is an Equal Opportunity Employer and E-Verify participating employer