Regulatory Affairs Specialist | InControl Medical

Regulatory Affairs Specialist

InControl Medical

Supervisor: Director of Quality Assurance

Position Supervises: None

Job Summary:

The Regulatory Affairs Specialist is responsible for the company’s regulatory functions. This position provides direction to the business regarding regulatory requirements for product launch, submissions, and post market compliance. The role will also assist in implementing quality assurance polices throughout the company to certify that InControl Medical, LLC’s products are manufactured consistently and in accordance with standards of quality and current good manufacturing practices (cGMPs). The Regulatory Affairs Specialist will ensure that all product and processes meet US Federal regulations, international regulations, ISO standards, the company’s own quality requirements, and other standards as they arise.

Essential Duties and Responsibilities: 

  • Provides guidance in interpreting government regulations, agency guidelines, and internal policies to assure compliance
  • Ensures that regulatory requirements for countries/regions are accurately documented and followed
  • Ensures the inclusion of applicable regulatory requirements in product development for target countries
  • Prepares regulatory submissions by working with cross functional team members
  • Prepares and files regulatory renewal applications to ensure continued market access
  • Assesses changes in existing products and determines the need for new/revised licenses or registrations
  • Reviews advertising and promotional material and consults with the marketing team on approved claims and regulatory requirements
  • Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions
  • Supports regulatory inspections
  • Maintains and leads the organizational internal audit program
  • Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations
  • Assists in ensuring that the Quality Management System performance is measured and routinely reported to management
  • Ensures regulatory filing strategies are developed and supported through product development and lifecycle management
  • Assists in the surveillance of the company’s Quality and Regulatory departments to ensure operational success
  • Assists with the risk management and design control strategy for the development and manufacture of new and existing devices
  • Ensures activities are completed within scheduled timeframes (e.g., regulatory submissions and reports, investigations, MDRs, etc.)
  • Contributes to writing and editing technical documents
  • Provides oversight to Medicare/DMEPOS regulatory compliance

The statements made in this job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job.

Skills and Qualifications:

  • Demonstrates strong analytical, problem-solving skills
  • Strong written and verbal communication skills
  • Detail-oriented, good organizational traits
  • Self-motivated
  • Candidate must be results oriented and show a strong track record of meeting deadlines
  • Good computer skills

Physical Demands:

  • Frequently required to sit for extended periods of time
  • Frequently required to use hands to manipulate keyboard, direct tools, controls, and products
  • Frequently read handwritten and/or computer-generated material
  • Regularly required to talk and listen
  • Occasionally required to lift up to 20 lbs.
  • Occasionally travel to visit vendor sites throughout the U.S. and internationally

The physical demands described here are representative of those that must be met by employees to successfully perform the essential functions of this job. The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “occasionally” means up to 1/3 of working time, “regularly” means between 1/3 and 2/3 of working time, and “frequently” means 2/3 and more of working time.

Hazards:

  • Potential for exposure to toxic or caustic chemicals
  • Potential exposure to bloodborne pathogens

 

Education and Experience:

  • Significant experience in regulatory-related work assignments
  • Bachelor’s degree or higher in Science, Engineering, or similar field, or equivalent experience
  • Medical Device industry experience required
  • Experience with international medical device regulations and requirements preferred
  • Professional certification (e.g. ASQ CQA, RAC) preferred
  • Demonstrated proficiency in Quality System Regulations (QSR), 21 CFR 820, MDSAP, MDR, DMEPOS (Medicare), ISO 13485 Standards and other industry regulations related to medical devices
  • Demonstrated track record in successful regulatory submissions (510(k), MDD/MDR Technical Files) and requirements preferred
  • Accomplished user of word processing, spreadsheet, and database applications
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form, including ability to read and interpret drawings and schematics
  • Ability to write clear instructions and reports
  • Experience with process mapping, design of experiments, root cause analysis, and other quality tools and techniques preferred
  • Ability to communicate effectively (both written and oral) with other employees in the organization

Company Benefits:

  • 10 days paid time off
  • Paid holidays
  • Participation in our company health care plan, employer pays 70% of premiums
  • Option to enroll in our voluntary dental, vision, life, and short & long-term disability insurances

InControl Medical management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

To apply for this job email your resume to jford@incontrolmedical.com