Regulatory Specialist

Job Description

Job Description

Education and/ or Experience Required:

1.       Minimum: Bachelor’s Degree in Science, Health Care, Engineering, Mathematics, Statistics or other technical field; or five years related experience and/or training; or equivalent combination of education and experience.

2.       Previous job in Regulatory Affairs/Quality Assurance within the Medical Device Industry preferred

3.       2+ years working in area quality assurance or regulatory industry; 1+ more years conducting quality audits in a regulated medical company

4.       Experience communicating with customers preferred.

Job Information

Perform Compliance management, Regulatory functions as listed in job description and perform other related miscellaneous tasks/duties as assigned and required.

Qualifications  

The following qualifications are preferred:

§  Active Learning

§  Active Listening

§  Critical Thinking

§  Learning Strategies

§  Self-Assessment

§  Excellent communication and listening skills

§  College level Reading, Writing and Speaking (English)

§  Problem Solving

§  Attention To Details

§  Proficiency in MS Programs

§  Professionalism

§  Handles Pressure

§  Knowledge and understanding of FDA and international regulations as well as other quality standards (e.g. ISO9001, ISO13485).

Essential Duties and Responsibilities - Duties may include but are not limited to:

1.       Regulatory Affairs:

§  Lead or assist with medical device license registrations

§  Lead or assist international customers with international registrations

§  Lead or assist in the development of product and regulatory documentation (Technical Files, etc.)

§  Assist with identifying and ensuring compliance with applicable quality-related standards and assessing and implementing any required changes.

§  Assist with ensuring Regulatory requirements are met via creating, reviewing and/or maintaining all “REGU-related” materials (Operating Procedures, Work Instructions, labeling, etc.).

§  Member of Regulatory Team. Responsible for ensuring that:

o   the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

o   the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

o   the post-market surveillance obligations

o   the reporting obligations with competent authorities.

§  Collaborate with applicable functions to support:

o   Pre- market notifications, registrations and licenses.

o   Regulatory authority applicable notifications for product changes resulting from Deviations and/or Change Orders (COs).

o   Notification of customers, distributors and regulatory authorities of related notifications of regulatory concerns (Example: FDA Warning Letter).

o   Issuance of advisory notices.

§  May serve on internal committees related to customer complaints, recall, recovery, CAPA,  field correction boards, etc.

§  Completes and submits any supplementary documentation/forms to applicable countries or in country sponsor as required by country regulation.

§  Attend Design Meetings representing the Regulatory Department.

§  Participate and assist with internal and external audit activities, as needed.

o   Complete documentation for internal and external audits.

§  Perform other related duties and responsibilities, as assigned.

2.       Additional Duties:

§  Participate in various meetings as needed.

§  Member of the Quality Steering Team as needed.

§  Perform other related duties and responsibilities, as assigned.

Supervisory Responsibilities: None