Apex Systems is looking for a Regulatory Program Manager
. Tasks and responsibilities:
Summary: This position is responsible for overseeing all deliverables to ensure the site is ready prepared to handle transfer of regulatory responsibility for a device between two facilities. This candidate will be coordinating with cross-functional teams, including but not limited to Marketing, Operations, Quality, Regulatory and Supply Chain to ensure that all deliverables are completed correctly and delivered on time.
Preferred Educational Background:
- Knowledgeable of regulatory requirements, e.g. QSR's, ISO 13485, FDA GMP & 820 regulations, IVDR directive in EU.
- Develop necessary project plans locally and manage reporting on project progress and achievement of key milestones.
- Oversee project to make necessary updates to Quality System requirements across all functional areas to prepare for transfer of the product.
- Experience writing Standard Operating Procedures and upgrading Quality Systems to align to new requirements.
- Coordinate transfer of a Design History File from one location to another while managing in process deliverables.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Perform other duties & projects as assigned
Bachelor's Degree in related fieldPreferred Experiential Background
- Minimum 5 years' experience in Quality or Operations within the healthcare or biotechnology industry
- Extensive experience leading projects to completion.
- Demonstrate ability to effectively and constructively communicate across departmental disciplines while pursuing project goals
- Proven ability to provide sound conclusions and recommendations
- Understanding of new IVDR requirements
- Understanding of ISO 13485 and FDA, EU requirements
- Strong communication and leadership skills
- Demonstrate organizational skills with a focus on detailed work
- Ability to initiate and manage multiple tasks in a fast-paced environment
- Must be able to work as part of a team, meet deadlines & take instruction from multiple persons
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.
Posting ID: 559413734Posted: 2020-06-03