In this position, you will be responsible for supporting company regulatory compliance documentation requirements, supporting compliance with ISO 9001 total quality standards; supporting developmental stage of new products and suppliers for Regulatory Compliance; supporting customer and supplier audits; and interfacing with customers and suppliers on regulatory issues.
Specific responsibilities include:
- Participate in the Change Notification Team.
- Organize and coordinate tasks involved in completing any testing required for regulatory product approvals (European Directives, EC markings, etc.).
- Participate in new product development process by maintaining regulatory files and applicable toxicity information on Company products as well as purchased and sample components.
- Organize, coordinate and conduct / implement audits and inspection for the purpose of assessing regulatory compliance. Participate in customer QMS audits.
- Support the Customer Complaint process by assisting in complaint investigations and responses to customers as needed.
- Compile information provided by various departments and perform submittals of new Drug Master File submissions and amendments for US and Canada. Maintain FDA Letter of Authorization contact lists, submit FDA annual reports, and notifications to customers for DMF changes.
- Support EU compliance including Pira Certifications, REACH Regulation, CLP Regulation and A&I Packaging Regulation
- Coordinate implementation and use of electronic Quality documentation system for all plants.
- Assist Sales / Marketing and Technology in providing regulatory compliance statements to new or existing customers of Multisorb's products.
- Participate and provide leadership in activities supporting the ISO / quality systems.
To qualify, you must have a bachelor’s degree in an Engineering or Science discipline. A degree in Chemistry, Biochemistry, or Chemical Engineering preferred. A minimum of 5 – 7 years experience in regulatory affairs or quality assurance for a company supplying an FDA regulated marked required; experience working in a high speed new product development environment required; experience working in a cGMP manufacturing environment required; must have demonstrated experience leading teams, special projects or initiatives; quality system leadership experience required. Leadership experience in an ISO quality system and internal auditing desirable. Experience with regulatory submissions and working with regulatory agencies desirable.
The successful candidate will have strong verbal and written communication skills; ability to organize the flow of information and translate it into meaningful reports that have good data presentation and are written in proper form; knowledge of all regulatory requirements applicable to the manufacture of the product; strong project organization and management; experience training others; goal-oriented with ability to make action plans to meet goals; adept at problem-solving through use and utilization of scientific methods; knowledge of applicable specifications and standards; strong leadership and influencing skills.
Multisorb Technologies - 9 months ago