Regulatory and QA Manager

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.

 Responsibilities:

• 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.