File Manager
Company: SunMed
Location: Grand Rapids
Posted on: April 10, 2021
|
|
Job Description:
The Technical File Manager is responsible for establishing and
sustaining Technical Files and related technical documentation.
This position will ensure that Technical Files and related
documentation is revised as product changes are planned and
executed. They will coordinate efforts associated with the
preparation of regulatory documents and submissions (i.e. Tech File
audits, 510(k) submissions). This position communicates with
regulatory agencies regarding submission strategies, potential
regulatory pathways, and compliance test requirements. The
Technical File Manager will represent SunMed Technical Files during
internal and external audits. Likewise, this position will work
with customers on technical documentation requests.The Technical
File Manager must identify evolving and relevant guidance,
standards, and requirements and implement them in the Technical
File process.
Position QualificationsThe specific minimum competencies needed to
perform the essential duties of the job include knowledge, skills,
abilities, level of education, and experience necessary for
successful performance. These competencies are generally
demonstrated through specific service, education, or training.
Knowledge: Acquired through education, certifications, training,
experience.
Level of Experience:
Level of Education:Bachelor degree or equivalent work
experience.
Travel:Occasional overnight travelUp to 10%
Essential Duties and ResponsibilitiesThe core tasks, duties, and
responsibilities that must be performed on the job.
Other Responsibilities
Quality Policy:At SunMed, Quality is our promise. It is our
commitment to customer satisfaction and our dedication to product
excellence in an evolving global healthcare market. This promise is
kept through a continuously improving and effective Quality
Management System and compliance to Regulatory
Requirements.ExcellenceWe are dedicated to providing the quality of
excellence through teamwork, leadership, open communication and
continuous improvement to achieve the company's objectives and meet
our customer's expectations.Continuously improve the effectiveness
of our Quality Management System that delivers compliant and
sustainable products, processes and systems.CustomersWe will adapt
to customers changing needs at all times in an environment of
continuous improvement of high quality products and
services.ProductsWe distribute products that are safe, reliable and
in compliance with applicable US and International regulatory
requirements, standards and regulations.
#sunmedcareers #regulatory #technicalwriter #GRJobs
#medicaldevice
Keywords: SunMed, Grand Rapids , File Manager, Executive , Grand Rapids, Michigan
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsSalon Manager - Merrifield Plaza Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Rolling Prairie Posted on: 04/16/2021 Assistant Salon Manager - Erskine Village Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Granger Posted on: 04/16/2021 Assistant Salon Manager - Warsaw Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Warsaw Posted on: 04/16/2021 Salon Manager - Martin's St. Joseph Plaza Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Saint Joseph Posted on: 04/16/2021 Salon Manager - Shoppes on Six Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Nappanee Posted on: 04/16/2021 Assistant Salon Manager - Clocktower Lane Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: South Bend Posted on: 04/16/2021 Assistant Salon Manager - Goshen Commons Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Middlebury Posted on: 04/16/2021 Salon Manager - Erskine Village Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: North Liberty Posted on: 04/16/2021 Salon Manager - Wabash Village Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Macy Posted on: 04/16/2021 Assistant Salon Manager - Martins Super Center Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, Company: Great Clips Location: Dowagiac Posted on: 04/16/2021 |