The Regulatory Affairs Associate works cross-functionally with all departments to ensure new products and programs are in compliance with all regulatory agencies governing the company, as well as ensuring compliance with internal policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions. Ensuring that departmental timelines are met.Reviews technical documents for accuracy and acceptability for use in new NDAs, Amendments, Supplements, Annual Reports and other required FDA filings to ensure high quality submissions and expeditious approvals from FDA.Reviews and signs-off on change control documentation. Assess changes and their impact to the business based on understanding of regulatory guidelines and applicable federal laws.Represents Regulatory Affairs in project team meetings and provides regulatory perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.Alongside Senior Manager, ensure regulatory program compliance for the company.Monitor and assist Quality Control department in the maintenance of the Quality Management System (QMS) to ensure compliance with FDA and other regulatory requirements.Assist in the internal audit process, including the participation of GMP audits of the production facility on a regularly scheduled basis, and as necessary.Alongside the Senior Manager, assist in the external audit process, including preparation for ISO 13485 and customer audits.Assist in review of customer and regulatory requirements to ensure company compliance and to stay abreast of new or updated regulations.Secondary for ISO 13485 Management Representative.Secondary FDA contact, including assisting with the annual FDA registration updates and keeping Drug and Device listings current.Assist in ensuring regulatory compliance of all materials and products.Assist in reviews of NCMs to ensure trends or systemic issues are identified and addressed.Assist in analyzing audit data and prepare reports for Management Review and continuous improvement initiatives.Assist in performance tests of controls to provide an evaluation of the company’s internal control system, and prepare audit reports for these tests, documenting exceptions to established policies and procedures.Alongside the Senior Manager, perform external quality audits on suppliers to ensure compliance with product specification.Assist in overseeing the maintenance of Quality and Audit files for facility.Assist in overseeing all Change Control activities to ensure compliance.Assist in review all release documents to ensure compliance with Standard Operating Procedures (SOPs)..Assist in ensuring compliance with GMP, QSR/ISO, FDA, NSF, NRC, ATF, OSHA, and all other regulatory requirements, in accordance with company policy.Assist in overseeing all environmental health and safety programs of the facility.Data entry and interpretations of various KPIs and processes of the facility.Regular attendance required.Adhere to company safety requirements.

MINIMUM REQUIREMENTS:

Minimum of a Bachelor’s Degree in a life science or a related field, or a combination of equivalent education and experience.Auditing certification preferred.Excellent analytical and problem-solving skills.Demonstrated leadership skills and ability to get results through others.Good communication and interpersonal skills.

Proficient with Microsoft Office (Word, Excel, Project).Ability to manage multiple projects and prioritize to meet established timelines.

PHYSICAL REQUIREMENTS:

Frequently required to sit, talk, and hear.Frequently required to stand and walk.Occasionally required to lift up to 20 pounds.Vision ability including close vision, distance vision, and the ability to adjust focus.Ability to travel occasionally by air or car to attend business meetings and conduct audits.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Pay Range: $21.00-$26.00

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an “at-will” basis.

Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status.

Silgan is a drug-free workplace.