Location: Grand Rapids
Posted on: April 10, 2021
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
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,
- Knowledge of quality standards and regulations for medical
devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives and
EU Medical Device Regulations, and Canadian Medical Device
Regulations). Skills & Abilities:
- Excellent technical writing skills.
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Ability to multi-task.
- Excellent critical thinking, using logic and reasoning to
identify the strengths and weaknesses of alternative solutions,
conclusions, or approaches to problems.
- Active learning - understanding the implications of new
information for both current and future problem solving and
- Excellent time management.
- Strong computer skills: MS Word, MS Excel (chart, pivot
tables), PowerPoint, and database management.
Level of Experience:
- A minimum of 5 years of Quality and/or Regulatory experience in
an FDA regulated and/or ISO certified facility (preferably ISO
Level of Education:Bachelor degree or equivalent work
Travel:Occasional overnight travelUp to 10%
Essential Duties and ResponsibilitiesThe core tasks, duties, and
responsibilities that must be performed on the job.
- The Technical File Manager is responsible for establishing and
sustaining Technical Files and related technical documentation.
Compile and maintain regulatory documentation, databases, and
- Coordinate efforts associated with the preparation of
regulatory documents and submissions (i.e. Tech File audits, 510(k)
- Develop and conduct regulatory training related to technical
- Communicate with regulatory agencies regarding pre-submission
strategies, potential regulatory pathways, compliance test
requirements, or clarification and follow-up of submissions under
- Coordinate, prepare, or review regulatory submissions for
domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they
are communicated through corporate policies and procedures.
- Provide technical review of data or reports that will be
incorporated into regulatory submissions to assure scientific
rigor, accuracy, and clarity of presentation.
- Determine the types of regulatory submissions or internal
documentation that are required in situations such as proposed
device changes or labeling changes.
- Maintain current knowledge base of existing and emerging
regulations, standards, or guidance documents.
- Participate in internal and external audits.
- Prepare or maintain technical files as necessary to obtain and
sustain product approval.
- Recommend changes to technical documentation procedures in
response to changes in regulations or standards.
- Review post-market surveillance activities, clinical evaluation
reports, and design documents to ensure collection of data needed
for technical documentation establishment or revision.
- Focus on achieving our Company mission
- Demonstrate accuracy and thoroughness in daily work; look for
ways to improve and promote quality, compliance, and safety.
- Inspire the trust of others; treat people with respect and
dignity, and embrace the value of diversity.
- Use time efficiently; perform job accurately, thoroughly, and
conserve Company resources to improve profits.
- Contribute to building and maintaining a positive team
- Assure all policies and guidelines are implemented and
- Communication - Effectively providing information to
supervisors and coworkers by telephone, in written form, email, or
- Developing specific goals and plans to prioritize, organize,
and accomplish your work.
- Analyzing information and evaluating results to choose the best
solution and solve problems.
- Developing constructive and cooperative working relationships
with others, and maintaining them over time.
- Performing day-to-day administrative tasks such as maintain
technical files and processing paperwork.
- Getting members of our organization to work together to
- Training others on the importance and requirements related to
technical files and documentation.
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
Keywords: SunMed, Grand Rapids , File Manager, Executive , Grand Rapids, Michigan
Didn't find what you're looking for? Search again!