SENIOR DIRECTOR - QUALITY ASSURANCE & REGULATORY AFFAIRS

 

Excelsior Medical Corporation is a New Jersey-based company that manufactures and markets pre-filled saline flush syringes, pre-filled heparin flush syringes, and syringe pump systems to customers throughout the United States and Canada. Excelsior?s clients include hospitals, home healthcare agencies, and medical device distributors.

 

Excelsior has an exceptional opportunity for a Senior Director of Regulatory Affairs and Quality Assurance.



 

Overview:

The Senior Director of Regulatory Affairs and Quality Assurance is responsible for developing, implementing and leading the quality assurance activities (i.e., GLP, GCP, GMP, 510K?s, PMAs, and international registration of products) for the company.  This individual will be accountable for ensuring compliance with regulatory standards in the development of products from early stage through approval and for developing effective relationships with the regulatory agencies, such as the FDA.

 



Position Description & Responsibilities



? Provides leadership for the development, implementation, communication and maintenance of quality systems policies and procedures in accordance with US FDA regulations and ISO requirements.

? Guides the organization on general quality compliance issues. Performs internal and external GLP, GMP and GCP audits, including suppliers and other third parties.

?In addition, responsibilities include interpreting worldwide regulations, guidelines, and cGMP, cGCP, and cGLP practices ensuring compliance, and advising senior management on relevant business requirements. 

? Manages documentation related to Quality System, ISO and FDA guidelines. Validates reports and other documents that comprise the registration package(s) for products. 

? Provides leadership for developing and directing Quality Assurance and quality improvement initiatives for all products and services. Manages and maintains the Company?s internal quality audit program and assesses improvement initiatives resulting from all Quality Audits, internal and external.

? Effectively interacts with Manufacturing and Product Developmentteamstomaintain product supply and help introduce new products.

 

? Develops regulatory strategy for successful agency approval of regulated medical devices. Leads interactions with regulatory authorities related to quality and compliance policies, guidelines, and systems

 

? Reports on a timely basis to executive management on the performance of the quality system, any non-compliance issues and recommended actions.

 

? Works in conjunction with the Quality Systems group to implement new programs and policies, including support for training the organization.

 

? Establishes and maintains a monitoring and trending program to ensure general state of compliance is under control and continuously improving.

 

?Formulates and manages the development and implementation of goals, objectives, policies, procedures and systems pertaining to the quality assurance and regulatory functions. Develops, implements, communicates and maintains a quality plan to bring the Company?s Quality Systems and Policies into compliance with ISO and FDA quality system requiremnts.

 

 

Education And Experience



? BA/BS in life sciences (advanced degree preferred) with 8 to 10 years experience managing Quality Assurance & Regulatory Compliance in the biotechnology,  pharmaceutical, or medical devices  industry.

 

? Experience interacting with regulatory authorities with successful preparation of 510K filing or CE mark filing. 

 

? Experience in ISO, QSR and QSIT-type audits.

 

? Working knowledge of design control processes. 

 

? Professional certifications (e.g. American Society for Quality (ASQ), Certified Quality Auditor (CQA) a plus).

 

? Solid understanding of cGMPs, GLPs, GCPs, ICH, and FDA guidelines, experience working with the FDA, and knowledge and experience with non-U.S. regulatory authorities preferred. 

 

? Proven ability to work effectively with various groups to assure conformance to regulatory requirements, internal processes, and policies.

 

? Excellent written and verbal communication skills required. 

 

? Demonstrated leadership ability and experience, including staff recruitment and development.

 

? Strong computer skills required with proficiency in MS office applications. 

 

? Demonstrated analytical and project management skills.

 

? Strong attention to detail and proven technical writing skills. 

 

? Strong interpersonal and management skills

 

? Excellent verbal and written communication skills. 

 

? Ability to thrive in a fast paced, start-up product development environment.