Regulatory Affairs Specialist
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Location: Tampa, FL
Salary: $50000 - $80000
Our client is a $350 M divison of a leading company in
the Medical Device industry, seeking a Regulatory Affairs
Specialist with two plus years of related experience. This
position will be responsible for completing regulatory files/submissions
for worldwide registration of products. Candidates will
have a Bachelor's degree and at least two years of related
experience. Dynamic company, desirable geographic location,
competitive package.
Packaging Engineer
Location: Tampa, FL
Salary: $60000 - $82000
Our client is a leading manufacturer in the Medical Device
industry, seeking an experienced Packaging Engineer to grow
with their dynamic group! The Packaging Engineer will have
experience in a similar role in the Medical Device industry,
or may come from Pharmaceutical, if have strong knowledge
of root cause analysis and wllingness to work closely with
design teams. Candidates will have an engineering degree
and at least two years of related experience.
Medical Device Job Title: Product Manager
Location: Tampa, Florida
Salary: $80000 - $90000
The primary function of the Product Manager is the profitable
growth of their product line. This requires the origination
and execution of product marketing plans, product launch programs,
identification of market and segment trends, specifications
of new products and enhancements and promotional programs
for products which meet the needs of customers across all
segments. Development and growth will be achieved through
comprehensive product, pricing, promotional and distribution
strategy development and execution as well as, a close working
relationship and clear product leadership role with the Sales
and Distribution Teams. The holder provides direction to product
development teams, including participation in the development
process through project leadership and working on teams within
GBU category management.
REQUIREMENTS: Education: Bachelor's Degree in business
administration or science required; MBA or higher preferred.
Experience: Minimum 3 years product management experience
required together with some sales experience or equivalent
in relevant advanced education. (Skin care or cosmetic experience
is a plus) s. Requires the ability to travel throughout
the US 30% of the time and to work with field sales employees
and customers.
Express Interest to: dapple@appleassoc.com
Medical Device Job Title: Regulatory Affairs
Specialist
Location: Tampa, Florida
Salary: $50000 - $60000
Our client is a leading manufacturer of MEDICAL and health
care related products, located near Tampa, FL.
Reporting to the Sr. Regulatory Affairs Manager , this position
will strategically and tactically organize the review of
regulatory documentation (510(k), IDE, PMA, periodic reports)
for submission to the FDA, and foreign regulatory bodies
in support of market clearance or product licensure. A focus
of this position will require working knowledge in the filings,
assist in the strategic design and preparation of responses
to inquiries from regulatory agencies, and will provide
support for the company's regulatory systems. In addition,
the position will lead projects, which will include internal
and external communication to meet established time lines.
QUALIFICATION REQUIREMENTS:
-Working knowledge of US, and preferably EU, powered DEVICE
registration development, construction, and review;
-A flexible attitude with respect to work assignments, new
learning and travel; .
-Ability to work professionally with highly confidential
information;
-Experience with Microsoft based applications and general
knowledge of PC functions;
-General knowledge of electronic submission requirements
and associated software programs.
-Working knowledge of electronic submission preferred (Documentum)
-Ability to manage multiple and varied tasks with enthusiasm,
and prioritize workload with attention to detail;
-Must possess considerable initiative and be willing to
work with multiple disciplines in a fast- -moving environment,
and to value the importance of teamwork; -Must posses excellent
interpersonal, organizational, and written communication
skills including ability to assume a leadership role;
-Must possess knowledge of FDA and International (e.g.,
EU) regulations and guidelines; and -Strong verbal, organizational,
and analytical skills and computer literacy required.
Required Skills
EDUCATION AND/OR EXPERIENCE: Bachelor's degree in scientific
discipline required. 2-3 year minimum experience within
Regulatory Affairs Department--experience in technical writing,
and display of a knowledge of FDA and International regulations/requirements
as they pertain to DEVICE submissions.
COMPUTER SKILLS: Fluent in Microsoft Work, Excel, and working
knowledge of internet (Microsoft explorer) functions. Electronic
submission software [Documentum] experience preferred.
Express Interest to: dapple@appleassoc.com
Medical Device Job Title: Associate Product Manager
Location: Fort Lauderdale, FL
Salary: $80000 - $90000
Our client is a growing biotech/MEDICAL DEVICE manufacturer
in the south Florida area, offering exceptional career opportunity,
interview and relocation expenses covered, and competitive
compensation packate.
The Associate Product Manager, Knee Arthroplasty, will
support the Product Management team in defining the direction
of growth in the Knee Arthroplasty market space. The Product
Manager (PM) will work with engineering partners in Program
Management, as well as various engineering teams, to execute
product development projects. Interfacing with key customer
stakeholders (external & internal), the PM will ensure
that customer expectations will be met with designs in progress.
Responsibilities
1) Product Development ("Upstream Marketing")
Identifies, defines and presents new and existing product
development opportunities and strategies to management.
This includes building a business case.
Generates Customer Requirement Specifications for products
in alignment with the requirements of our Product Development
process SOP's.
Supports the Clinical Training Manager in the development
of clinical training materials and curriculum as part of
a product launch.
Actively participates in product development programs and
meets on a regular basis with project level leader teams
to support the overall efforts of releasing and launching
products in a timely manner.
Attends cadaver labs and supports the coordination of getting
key surgeons to attend cadaver labs and/or clinical testing
of new products as part of design validation process.
Ensures deliverables of Product Management are performed
within Quality System and in compliance with our Business
Conduct policy.
Participates in the selection, nominations and management
of clinical Advisory Board and Design Advisory Board Members.
This includes coordinating meetings as required to support
development process, whether in person or by teleconference.
Defines needs for clinical studies (both PMA and pos 510k)
in conjunction with CAB/DAB Members and Clinical Affairs
Manager as required.
Determines list pricing for all assigned products via thorough
competitive analysis, market trends, etc
2) Market Analysis
Develops and maintains market information system
Researches, analyzes, and remains informed about competitive
products
Develops and refines Price Strategy and Competitive Pricing/Share
Analysis
3) "Downstream Marketing" and Sales Support
Defines outbound sales collateral needs in conjunction with
sales management and delivers through Marketing Communications
function.
Delivers sales training materials from time to time, in
particular around product launches.
Attends clinical meetings and trade shows. Assists Marketing
in overall convention strategies and goals.
Qualifications:
Bachelors in Business/ Marketing or Science/Engineering
Related Discipline; MBA preferred.
3+ years of technical or marketing experience in MEDICAL
DEVICE industry
Proven ability to determine and communicate effective product
positioning and key marketing strategies
Demonstrated ability to plan, organize, manage and execute
on several marketing projects simultaneously
Proficient in multiple computer based tools (MS Word, Excel,
Publishing, Acrobat etc.)
Knowledge of regulatory issues in MEDICAL DEVICE industry
Track record in managing and meeting budgets on product
development projects
Proven ability to handle complex negotiations and experience
with senior level managers and surgeons
Strong analytic marketing knowledge and experience
Experience leading a product design team with surgeon participation
or led a surgeon advisory board preferred.
Express Interest to: dapple@appleassoc.com
Medical Device Job Title: Associate Product Manager/Product
Manager
Location: Miami, FL
Salary: na
Latin American division of $10 Billion company is seeking
an Associate Product Manager/Product Manager (depends on
experience) to develop production and marketing strategies
to ensure effective placement relative to market opportunity,
working closely with product development for a specific
product, brand or product area. Obtains technical design
and cost information to determine the profitability and
viability of new products or product enhancements. Must
ahve experience in development and implementation of strategy;
set up and conduct training programs for reps and end users;
must drive sales and margin growth by making field visits,
focusing on product, and will need to know how to allocate
resources per need. Must be bilingual (English/Spanish),
Portuguese a plus and have prior sales and marketing experience
supporting Latin America, in a MEDICAL related field preferred.
Will require travel to Latin America.
Express Interest to: dapple@appleassoc.com
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