At Beckon, we are looking for talented, results-driven contributors share in our mission and values. We are interested in building a diverse global workforce that represents Beckon’s wide range of business areas, regions and functions.
Once with our family, you can expect to contribute actively and be challenged through career and learning opportunities. We ensure each contributor has clear expectations for accomplishments, training, and growth. Expect to receive coaching and feedback as well as access to educational programs.
If you are interested in joining Beckon Scientific, send your resume to email@example.com.
List of current opportunities:
- Regional Quality and Regulatory Affairs Manager
At Beckon Scientific , every day is an opportunity to grow in our thriving and evolving business. We are a new organization that markets Disposable Medical Devices and Generics Pharmaceutical Products to Health Care Institutions in Latin America providing premium service to our valued customers.
At Beckon Scientific the strength of teamwork and a positive attitude of sharing knowledge, incorporating high caliber talent and using creativity and technology are key components to help us to growth our organization as we committed to investors.
We are looking for an experienced Quality and Reguatory Affairs Manager with solid organization, interpersonal and project management skills.
The ideal candidate will conduct all work with accuracy, on schedule, and to completeness while maintaining professionalism and the highest level of service.
The Quality and Regulatory Affairs Manager will practice regular communication and cooperation with other departments within the company, professionally handle and protect sensitive test subject data and contribute in a strong team environment.
incumbent will be responsible for coordinating all quality assurance and regulatory compliance activities within the company and will be supported by outside regulatory consultants with expertise in the field. The position is responsible for the maintenance of the quality system compliant to ISO standard and FDA medical device and drugs requirements including internal audits and training activities.
The position is also responsible for keeping abreast of any regulatory requirements or changes applicable to the product commercialization in Latin America target markets and communicating these requirements to the Executive Team. This position will support all regulatory submissions for the products in Latin America LATAM supported by local Beckon Scientific counterparts.
The position is based in Miami, Florida at our headquarters location
Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell our products in the Latin America Region .
Manages and oversees the Quality Management System; responsible for “Master Control” tool implementation and administration ensuring the best and most current practices are leveraged
Collaborates internally and externally to determine customer requirements and ensure they are met
Partners with critical suppliers to maintain the highest rate of supplier performance and compliance
Supervise Quality agreements with our existing suppliers and potential new ones
Plan and execute vendor audits directly or by means of our supporting network of country advisors Establishment and use of metrics to monitor the suitability and effectiveness of the QMS.
Develops, maintains and follows ISO procedures and GMP requirements pertaining to medical devicesevelops, maintains and generics)
Advises personnel and project teams on quality system and regulatory requirements, coordinates and presents regulatory information, and negotiates with management and regional colleagues to ensure requirements are met
Ensures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or pharmaceuticals commercialization responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures
Coordinate with external consulting resources as needed
Develop SOP’s as required to formalize our internal processes
Manage the Internal Audit, CAPA program and Supplier CAPA program
Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for effectiveness
Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality System
Manages regulatory affairs in support of medical device and pharmaceuticals including manufacturing in our CMO’s supporting clinical, preclinical, and marketing issues
Supports planning, preparation, and submission of US FDA reports as needed
Provides strategic regulatory insight regarding product development plans
Manages interactions with FDA, and other regulatory authorities
Maintains regulatory and all controlled documents in our “Master Control” environment
Coordinates and is responsible for completion of Latin America product registrations and providing regulatory information required supported by Country Teams.
Responsible for regulatory review and approval of product labeling, marketing and advertising documents.
Schedules and facilitates regulatory compliance audits
Manages the complaint process, FDA Medical Device and Pharmaceuticals Vigilance assessment and reporting to domestic and regional regulatory agencies
Manages customer complains from technical perspective
Implements a sample retention program and pharmacovigilance process as necessary
Develop and deliver Quality Assurance and Regulatory training.
Supervise products incorporation to inventory, reviewing each transaction from Quarantine to Approved status into ERP system verifying our foreign locations process compliance with our centralized system
Minimum of 8 years experience leading an organization in quality and/or medical device/pharmaceutical related discipline
Leadership experience in multiple areas of Quality Assurance required. Experience in Quality System design and improvement required
Knowledge and application of the principles of the Quality System Regulations and other international regulatory requirements governing medical device, generics pharmaceutical manufacturing and distribution required
Advanced Strong leadership skills. Ability to partnering in building and developing a new organization
Experience directly managing others required
Hands on approach
Winning, can do attitude. Innovative, results oriented approach. Customer focused
Excellent verbal and written communication skills in English and Spanish
Strong knowledge of ISO/FDA regulations and procedures for medical devices and pharmaceuticals
Familiar with FDA Establishment Registration, FDA Device Listings, FDA Certificates to Foreign Government
Experience as a cross-functional project manager (Can effectively work with legal, marketing, sales, engineering, IT, and operations groups)
Familiar with technical details of medical devices/generics pharmaceutical, concepts, practices, and procedures
Adaptability with the use of new information technology which is a pillar of our service strength
Ability to read, analyze, and interpret standards and regulations
Ability to manage critical projects to deadlines as part of an interdisciplinary team
Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers in English and Spanish
Must work well in a early stage company environment and understand that this role requires to act as a creative partner of a new enterprise, out of the box thinking mentality and capable to challenge adversity of the initial stages
Strong attention to detail and excellent organizational skills are required
Ability and willingness to work flexible/extended hours and light travel may be needed to support the business
Bachelors or other advanced education required, desired Life Sciences or Engineering
Desirable ASQ CQA and/or CQE certified
The role will have Regional Country Quality and Regulatory Mgrs direct reporting
The position reports to the COO
Beckon Scientific offers a competitive benefit package.
Beckon Scientific is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Job Type: Full-time (Posted Dec 11, 2015)
If you are interested in joining Beckon Scientific, Please send your resume to firstname.lastname@example.org