Job Title: Quality Assurance and Regulatory Affairs Manager
Company: Oricare, Inc. (oricaremed.com)
Location: Quakertown, PA
Date: April 2019
- Manage the Regulatory Affairs and Quality Assurance function.
- Develop global regulatory strategies for new and modified medical devices.
- Provide leadership to regulatory development teams, e.g., global regulatory strategies and cross-functional alignment with issues of possible regulatory ramifications and mentoring of regulatory staff.
- Act as a liaison with other departments, e.g., R&D, Legal, and Marketing for major initiatives.
- Provide technical guidance and training to RA staff: strategy formulation, submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.
- Review product and manufacturing changes for compliance with applicable regulations (Change Control).
- Review protocols and reports to support regulatory compliance and submissions.
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
- Build partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
- Own all aspects of the Quality Management Systems (QMS) including, but not limited to, CAPA, complaints, MDR, vigilance reporting, nonconforming material reports, internal audits, management review, etc.
- Support all Company initiatives as identified by management and in support of the QMS, Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) and international regulations (including, but not limited to, ISO 13485), other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform other related duties and responsibilities, on occasion, as assigned.
- Ensure conformance with Company policies, operating procedures, processes, and task assignments.
- Degree in engineering or physical science
- Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 4 years of technical experience.
- Minimum of 3 years of medical device regulatory experience preferred.
- Extensive experience with U.S. and global medical device regulations and submissions.
- Experience working in a broader enterprise/cross division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced, changing environment.
- Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational, planning, and follow-up skills and the ability to hold others accountable.
- Ability to travel approximately 10%, including internationally.
- Ability to maintain regular and predictable attendance.
About Oricare, Inc.
The Oricare team is a group of experienced professionals who have a thorough understanding of healthcare, customer needs and technological trends. With prominent past achievements working at leading medical device firms, the team is full of passion, rich in experience, and equipped with advanced knowledge and skills. As a diversified healthcare company, Oricare focuses on improving people’s lives by providing high-quality surgical products and comprehensive services utilizing the latest innovative technologies. Leveraging their engineering, marketing and operations experience, as well as fundamental knowledge of healthcare customer needs, Oricare integrates technology and design into high-quality, customer-oriented medical device solutions.
To apply, please send your resume and salary requirements to Jim Geier, President and CEO, Human Capital Consulting Partners, at email@example.com.