Job Reference: CF234
Regulatory and QA Manager
- Mississippi, Mississippi
- £0 - £0 per hour
- Permanent / Full Time
Seven Life Science have an amazing opportunity available as a Regulatory and QA Manager, this role is based in Mississippi, U.S.
Salary is negotiable.
- Oversee, coordinate, and implement regulatory strategies, budgets, and operations as directed by senior management.
- Maintain a Quality and Regulatory compliant company to ensure continual company operation and growth.
- Research and maintain up-to-date knowledge of U.S. importing/exporting policies and regulations.
- Ensure strict adherence to U.S. government and international rules, regulations, and standards.
- Provide regulatory expertise to ensure that planning and implantation of any/all company strategies are compliant with regulations and standard operating procedures.
- Work with Senior Management and business development teams to develop new business streams in compliance with governing rules and regulations.
- Generate and maintain company standard operating procedures in good form.
- Maintain knowledge of all regulations; ensure compliance of with all Regulatory agencies
- Prepare for and oversees Internal and External Audits.
- Oversee company quality policy to ensure that business processes and procedures are adhered to.
- Maintain working knowledge of FDA or other regulatory agency guidelines and regulations, as appropriate for specified product line at both the state and federal level.
- Communicate with regulatory agencies to ensure company compliance and defend company interests.
- Ensure that all commercially needed licenses required to operate the business are in place and current
- Ensure that department strategy is fully integrated with the commercial and supply chain strategies.
- Develop, implement, and maintain systems, activities, and programs within the FDA and international regulatory guidelines; identify key company success factors.
- Manage daily operations of Regulatory department. Coordinate tasks and efforts of subordinates.
- Develop performance measurement systems and departmental benchmarking techniques for items processed, workflow, and associate training progression.
- Implement continuous process improvement methodologies for Quality Assurance.
- Review and sign company agreement, confidentiality statements, licenses applications, and other company documents as the responsible person.
- Maintain company records and Secretary of State filings.
- Atten conferences and training seminars related to company regulatory and compliance policy.
- International travel required based on business needs.
- Any other duties assigned by your manager.
Qualifications and Experience Needed:
- 4 to 7 years’ experience in the Regulatory or Compliance field.
- Knowledge concepts, practices, and procedures of industry.
- Knowledge of International regulations required’ strong international experience preferred.
- Management experience demonstrating strong mission and vision.
- Excellent oral and written communication skills
- Proficiency with Microsoft Office Suite
- Ability to multitask.
- Attention to detail; organizational skills
- Strong problem solving and analytical skills.
- Adaptability and versatility in a dynamic environment.
- Leadership skills to effectively work in a team environment while maintaining group morale and mutual respect.
- Positive attitude and strong work ethic.
Working with Seven Life Science:
We have been helping professionals find exciting new roles for almost a decade, so we know exactly where to look when it comes to sourcing the best opportunities. We operate across the UK, and, with over 300 five-star reviews, multiple awards and amazing relationships with the biggest employers in UK Life Science, we give you the best chance of landing your next role.
We have a reputation for recruiting at lightning speed, however, we can only respond to candidates who meet the exact requirements of the position. If you have any queries about a role or application, please visit our website where our amazing candidate support team will be more than happy to help.