Manager, Regulatory Affairs - LATAM
Posted on: May 5, 2021
Requisition ID: 47494 Title: Manager, Regulatory Affairs - LATAM
Division: Arthrex, Inc. (US01) Location: INC- Naples FL (US08)
Arthrex, Inc. is a global medical device company and a leader in
new product development and medical education in orthopedics.
Arthrex is actively searching for a Manager, Regulatory Affairs -
Latin America. The position is based at the Arthrex world
headquarters campus in Naples, Florida. Relocation assistance may
be available along with Arthrex's exceptional employee benefits and
work culture. Join our talented team at a growing global medical
device company focused on Helping Surgeons Treat Their Patients
Better---. Position Summary: Responsible for leading Latin America
regulatory staff and product registrations, including preparing
regulatory strategies and managing regulatory submissions. Duties
- Lead and manage day to day activities and Latin America
- Determine and support regulatory activities which lead to and
maintain regulatory compliance and approval for Arthrex devices in
- Support and advise cross-functional teams and communicate
regulatory requirements and challenges effectively to meet project
- Monitor Latin American regulations/guidelines and the impact of
changing/evolving regulations on submissions, practices, and
procedures, and communicate to appropriate stakeholders.
- Oversee and direct the development of priorities, timelines,
receipt of technical information from appropriate sources, and the
preparation of regulatory submissions for new products, amendments
of approved products, and submissions that support the maintenance
of existing licenses;
- Review and evaluate issues which may create regulatory or
business obstacles, and propose solutions;
- Review and approve marketing literature for Latin America;
- Allocation of resources and workloads;
- Assist in regulatory due diligence, as needed;
- Deliver regular updates of all relevant regulatory activities
and issues to the Senior Manager of Regulatory Affairs, The
- Bachelor's degree required.
- Advanced Degree (MS or PhD, or equivalent) preferred;
preferably in a Science or Engineering discipline.
- 5 years direct experience in Regulatory Affairs in a Medical
Device Company required. Orthopedics preferred.
- 3 years management experience required.
- Training in technical aspects of regulatory affairs
- Regulatory experience in U.S. required, OUS experience is
highly desirable. Knowledge:
- Advanced knowledge of regulatory framework and regulatory
requirements for Latin America.
- Novice knowledge of human physiology/anatomy and understanding
of relevant procedures, practices, and associated medical
- Intermediate knowledge of orthopedic terminology, surgery
principals, theories, and products.
- Advanced knowledge of current medical device regulations,
standards, guidance's and regulatory requirements for medical
devices in Latin America.
- Advanced knowledge of ISO 13485.
- Advanced knowledge of product lifecycle, product development
process, design control and change control.
- Intermediate knowledge of clinical trial strategy and study
design, and sponsor reporting requirements. Skills/Ability:
- Strong interpersonal and communication skills.
- Ability to work in fast paced environment.
- Advanced written communication skills.
- Ability to plan, evaluate, and improve the efficiency of
business processes and procedures to enhance speed, quality,
efficiency, and output.
- Internal and external communication and collaboration
- Knowledge and experience in business, supervision, and
- Ability to lead, develop, and effectively manage
- Strong interpersonal relationship building and employee
coaching/ development skills.
- Proficiency with Microsoft Office, Adobe, etc. Come Join the
Arthrex Family! Arthrex is a privately held global medical device
company that is a leader in new product development and medical
education in orthopedics. Arthrex's innovative spirit has pioneered
the field of arthroscopy and sports medicine and led to the
development of more than 1,000 innovative products and procedures
each year. More than 90% of Arthrex's products are manufactured in
the United States and exported to more than 100 countries around
the world. Arthrex continues to experience unprecedented growth and
demand for our products throughout the world. Arthrex's status as a
privately-owned, non-listed company enables us to give priority to
the needs of our customers for the good of their patients. Arthrex
stands unwaveringly committed to its corporate mission, "Helping
Surgeons Treat Their Patients Better", by delivering uncompromising
quality to the healthcare professionals who use our products, and
ultimately, the millions of patients whose lives we impact. Arthrex
headquarters in Naples Florida, where this position will be
located, which is approximately 2 miles from pristine white sandy
beaches of the Gulf of Mexico and surrounded by state of the art
golf courses; upscale shopping districts; numerous outdoor
activities such as boating, fishing, kayaking, wildlife
sanctuaries; and a restaurant scene that has been ranked in USA
Today's Top 10 Best Small Town Food Scenes in the USA for 2018.
Additionally, in 2019 the USA Today's Gallup Poll ranked Naples as
one of the Top Ten Cities for Overall Wellbeing in the country for
the fourth year in a row. Employees also benefit from Florida not
having a state income tax on earned income. Arthrex offers numerous
exceptional benefits such as free on-site gourmet lunch
Monday-Thursday, exclusive on-site medical center available to
employees and their family, exclusive access to onsite fitness
facilities, company bicycles, and much more! Arthrex proudly
invests in the professional growth of its approximately 3000 global
employees through its commitment to provide on-going career
development and training to further help employees' careers.
Arthrex prides itself on its strong, positive workplace culture
that recognizes and rewards hard work and dedication. Arthrex is
mindful of the effect our corporate activity has on the earth, and
we are committed to doing business in an environmentally-friendly
manner. As part of our social responsibility, we strive to maintain
customer satisfaction with the highest quality products developed
in an environmentally sustainable way and create a working
environment that supports these goals. We promote environmental
impact reduction in all product development stages, product sales,
and corporate facilities. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, age, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.Job
Keywords: Arthrex, Cape Coral , Manager, Regulatory Affairs - LATAM, Executive , Naples, Florida
Didn't find what you're looking for? Search again!