Careers

 

careers

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 careers@beckonsc.com.

List of current opportunities:

- Regional Quality and Regulatory Affairs Manager

OBJECTIVES:

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

 

JOB RESPONSIBILITIES: 

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

 

QUALIFICATIONS:

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 careers@beckonsc.com