NEW Regulatory Manager Opportunity-Medical Device!This Jobot Job is hosted by: Audrey BlockAre you a fit? Easy Apply now by clicking the Apply buttonand sending us your resume.Salary: $100,000 - $125,000 per yearA bit about us:We are a well established consulting firm that provides solutions to medical device company, pharmaceuticals and biologics.Why join us?Opportunity to wear different hats in a small company-lots of growth!People management if interestedStrong benefits and compensation packageOpportunity to work in multiple therapeutic and diagnostic areasJob DetailsJob Details:We are seeking a dynamic and experienced full time Regulatory Manager to join our team in the medical device industry. This is an exciting opportunity to play a key role in ensuring our organization's compliance with regulatory requirements. The successful candidate will be responsible for overseeing and managing most aspects of regulatory affairs and some quality assurance, ensuring that our products and processes meet the stringent standards set by regulatory bodies such as the FDA. Responsibilities:
- Develop and implement regulatory strategies and processes to ensure compliance with FDA and other relevant regulatory requirements.
- Manage all aspects of quality assurance, including developing and implementing quality control systems, conducting audits, and managing corrective and preventive actions.
- Lead and manage a team of regulatory professionals, providing guidance and support to ensure their continued development and success.
- Liaise with regulatory bodies and other external stakeholders, representing the organization in all regulatory matters.
- Review and approve all regulatory submissions, ensuring their accuracy and completeness.
- Monitor changes in regulatory requirements and industry best practices, ensuring that the organization adapts its processes and procedures accordingly.
- Work closely with other departments, providing regulatory expertise and guidance to support the development and launch of new products.
- Manage regulatory inspections, ensuring that all necessary preparations are made and that any findings are addressed promptly and effectively.
Qualifications:
- A bachelor's degree in a scientific discipline. An advanced degree is preferred.
- A minimum of 3-5 years of experience in regulatory affairs in the medical device industry, including experience with FDA regulations.
- Proven leadership skills, with experience managing a small team.
- Excellent knowledge of regulatory requirements and quality assurance principles.
- Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements and develop effective compliance strategies.
- Excellent communication and interpersonal skills, with the ability to liaise effectively with regulatory bodies and other external stakeholders.
- Strong organizational skills, with the ability to manage multiple projects and deadlines.
- A proactive approach, with the ability to anticipate potential regulatory issues and take appropriate action.
- A commitment to continuous learning and development, with the ability to stay up-to-date with changes in regulatory requirements and industry best practices.
Interested in hearing more? Easy Apply now by clicking the Apply button.