Positions Available

Quality and Regulatory Affairs Manager

POSITION SUMMARY

Provides Quality Systems and Regulatory guidance and is the subject matter expert in Quality and Regulatory Affairs for the business. Ensures a high level of FDA Quality System Requirements (QSR) and Regulatory Compliance (ISO 13485 and select international requirements).  Manages audits (FDA, ISO, customers, and suppliers), as well as the Complaint System. Acts as the Management Representative. Responsible for the Management Review process and Plant Quality Metrics.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Maintain QMS and product certifications
  • Define regulatory strategies and timelines for product submissions of medical products; Participate in Product Development teams, by providing regulatory strategy, timelines, and deliverables;
  • Assure the compliancy and quality of the technical file by guiding the responsible disciplines; Compile the submission files and obtain approvals in the USA (510(k)), Canada and Europe (MDD);
  • Monitor the global regulatory developments and deploy these new or updated requirements via the Quality Management System and/or training and coaching;
  • Develop and maintain regulatory affairs department procedures and process improvements;
  • Review marketing and communications material and assess compliance against relevant regulations and product requirements;
  • Review Engineering Change Requests and assess regulatory impact of product changes on regulatory strategy and submissions;
  • Works closely with the Manufacturing team to insure we produce high quality compliant products.
  • Assures successful third-party audits (notified bodies, FDA, customers and suppliers). Drafts audit responses and ensures associated corrective activities are implemented.  Maintains key relationships on quality issues.  Maintains confidentiality.
  • Assume the role of Management Representative. Develops and maintains Plant Quality Metrics and is responsible for the Management Review process.
  • Develops Project Quality Plans that outline the Regulatory and Quality Documentation Strategy.
  • Identifies continuous improvement opportunities and lead efforts to improve processes, reduce waste, reduce cost and improve customer service.
  • Manage complaint handling (investigation/ resolution), and agency reporting (MDR/Vigilance)
  • Manage document control and training functions.
  • Plans staffing requirements. Hires, trains and develops employees.
  • Ensures all Environmental testing is executed on time

POSITION REQUIREMENTS

            EDUCATION:

    • Bachelor’s degree (BS in an engineering, technical, business or related field).

            EXPERIENCE:

    • 5+ years related experience in similar position in a Medical Device Company

 KNOWLEDGE/SKILLS/ABILITIES:

    • Proven knowledge of ISO 13485:2016, MDSAP, and associated risk management activities (ISO 14971)
    • Proven knowledge of product CE Mark process, and new EU MDR requirements.
    • Absolute need to multi-task. This is a hands-on position that requires you to simultaneously lead the department but also have Quality Projects to Manage.
    • Ability to influence others to support quality.
    • Excellent interpersonal skills that foster cooperation and commitment.
    • Ability to represent CP Medical credibly as the manager of Quality and Regulatory Assurance.
    • Written and verbal skills must be excellent
    • Proven ability to use systematic approach to solving problems through analysis of problem and evaluation of alternative solutions.
    • Must be able to analyze technical documents, policies, reports, articles and research work to make informed decisions.
    • Computer and software proficiency (required), including Microsoft Office.
    • Detail-oriented with a sense of urgency for completing tasks.
    • Ability to deal effectively with a variety of internal and external operational and scientific personnel with varying degrees of education and experience.
    • Must be able to set priorities where multiple duties and projects are the norm.
    • Excellent work ethic, dependable, responsible.
    • Proven dependability and adherence to company attendance standards.

We offer a comprehensive benefits package that includes medical, dental and life insurance, long-term and short-term disability protection, vacation, paid holidays, sick days and a 401(k) plan.

CP Medical is dedicated to a policy of nondiscrimination in employment on any basis including race, color, sex, religion, national origin, marital status, disability, age, sexual orientation, gender identity, veteran’s status, or any other category protected by local, state or federal law. We take affirmative action to assure that all employment decisions are based on valid job requirements, and that equal employment opportunities are provided with regard to all personnel actions.

EEO Minorities/Women/Disabled/Veterans.

Sr. Quality Assistant

The Sr. Quality Assistant is a member of the Quality team and is responsible for managing the document control system and assists with managing the complaint program. The Sr. Quality Assistant may also be required to assist in other quality related activities as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Format controlled documents and manage routing of change requests for appropriate approvals and releases controlled documents
  • Serve as last quality check on all controlled documents
  • File, maintain, and safeguard quality control records, certifications, specifications, engineering drawings and regulatory files
  • Assist in maintaining databases for Quality Assurance Department
  • Manage the scheduled reviews of all controlled documentation
  • Assist in preparation of documents, as needed
  • Assist in complaint investigations
  • Test complaint-material lots and documents results
  • Issues complaint acknowledgement letters to customers
  • Process DCRs
  • Product configuration input into ERP system

POSITION REQUIREMENTS

EDUCATION:            

  • High School Diploma or Equivalent

EXPERIENCE:          

  • Five years’ related quality experience in a FDA-regulated industry.

KNOWLEDGE/SKILLS/ABILITIES:

  • Strong knowledge of formal document control systems in an FDA- regulated environment, including quality assurance principles and procedures.
  • Knowledge of QSD standards (e.g. ISO 10013)
  • Familiarity with electronic document management systems
  • Competence in MS Word, Excel, PowerPoint, Adobe Illustrator, Visio and SharePoint.
  • Ability to consistently attend to details.
  • Ability to develop efficient work procedures and processes.
  • Ability to influence others to action.
  • Ability to use considerable tact and diplomacy in dealing with others in a team-based environment.
  • Ability to work overtime as workload dictates.

We offer a comprehensive benefits package that includes medical, dental and life insurance, long-term and short-term disability protection, vacation, paid holidays, sick days and a 401(k) plan.

CP Medical is dedicated to a policy of nondiscrimination in employment on any basis including race, color, sex, religion, national origin, marital status, disability, age, sexual orientation, gender identity, veteran’s status, or any other category protected by local, state or federal law. We take affirmative action to assure that all employment decisions are based on valid job requirements, and that equal employment opportunities are provided with regard to all personnel actions.EEO Minorities/Women/Disabled/Veterans. CP Medical is a Drug Free Workplace.