Manager - Regulatory Affairs
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Position Reports To: Vice President - Regulatory Affairs and Quality Assurance
Position Directly Supervises: Complaint, Document Control, and Regulatory Affairs Personnel
Job division: RA/QA
Over-Time Status: Exempt
Purpose Of Position: Partners with stakeholders regarding product launches, product modifications, and changes to indications for use and determining registration strategy to obtain required market clearances in a timely fashion. Serves as the point of contact with regulatory agencies.
TO FULFILL THIS POSITION SUCCESSFULLY, AN INDIVIDUAL MUST BE ABLE TO PERFORM EACH ESSENTIAL FUNCTION SATISFACTORILY.
- Oversees assigned staff. Schedules, directs, assigns work, trains, and ensures tasks/projects are completed in a timely manner and adheres to operational standards.
- Interviews, hires, trains, and develops employees. Motivates employees, assists in goal setting, provides development opportunities and performance feedback, addresses complaints and provides resolutions. Addresses all employee relations matters in a timely manner in coordination with Human Resources.
- Reviews and develops standard operating procedures (SOPs) and departmental policies.
- Develops and implements regulatory strategy to ensure timely release of products in the US, Canada, and Latin American (LATAM) markets.
- Coordinates with various LATAM subsidiaries to submit documentation required for registration of products in each of the markets.
- Reviews and advises on proposed labeling, packaging, advertising and promotional materials. Communicates with US FDA, Health Canada, and global regulatory agencies.
- Participates in risk management activities and product realization processes.
- Analyzes and develops reports related to department metrics.
- Manages the preparation, submission, and submission tracking of FDA (510k) and International submissions.
- Maintains licenses and certifications from regulatory agencies.
- Processes change requests; prepares and files necessary regulatory documentation as required.
- Prepares US MDRs and events under international medical device vigilance systems as required.
- Oversees customer complaints to ensure appropriate action and closure.
- Supports internal, external, and third-party audits.
- Maintains awareness of US and global regulatory requirements/environment and effectively communicates these requirements throughout the organization.
- Provides guidance and assist other departments and divisions to ensure continued compliance and timely market release.
- Acts as the Recall Coordinator when required.
- Performs other related duties and projects as business needs require at direction of management.
The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add,subtract, or change the job function.
MINIMUM QUALIFICATIONS: THE REQUIREMENTS LISTED BELOW ARE REPRESENTATIVE OF THE KNOWLEDGE, SKILL, AND ABILITY NECESSARY TO SUCCESSFULLY PERFORM THE ESSENTIAL FUNCTIONS OF THE POSITION.
Education and Experience:
- Bachelor’s degree in a scientific discipline, preferred.
- Minimum seven (7) years of regulatory affairs experience.
- Previous experience working with FDA 510(k) submissions.
- Previous medical device experience required.
- Previous dental device experience preferred.
- Previous experience working with Health Canada and LATAM submissions, preferred.
- Regulatory Affairs Certification (RAC), preferred.
- Must be able to read and understand all standard operating procedures and applicable technical information.
- Proficient in English,both verbal and written communication skills required.
- Proficient in Spanish,both verbal and written communication skills a plus.
- Possess excellent interpersonal skills to effectively communicate with alllevels of personnel and general public in a professional and effective manner.
- Possess strong communication skills for frequent interaction with users, managers, and vendors.
- Abilityto create thorough and concise written technical documentation with proper English grammar and punctuation.
- Ability to communicate effectively in a multicultural work environment.
- Demonstrates judgment in daily interactions and work.
- Demonstrates an ability to establish sound professional relationships with employees across the organization and outside vendors/consultants/agencies.
Knowledge, Skills, and Abilities:
- Proficient knowledge of FDA 510(k) process.
- Proficient knowledge of regulatory affairs activities (Pre-Market, Post-Market).
- Demonstrated analytical decision-making and problem-solving skills.
- Demonstrated knowledge of procedures involved in creating standard operating procedures (SOPs) and guidance documentation. Ability to effectively create SOPs and guidance documentation.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
- Demonstrated knowledge of US MDR and International medical device vigilance systems.
- Ability to draft documentation compliant for FDA and International submissions.
- Ability to assess designs to determine regulatory classification and to file necessary regulatory documentation.
- Ability to determine need for and create CAPAs related to product complaints.
- Ability to read, interpret, and report on data related to department metrics.
- Ability to support internal and/or external audits as required.
- Ability to effectively prioritize and manage multiple tasks and available time.
- Ability to be dependable, reliable, and consistent in performing work.
- Ability to work independently with minimal supervision and effectively contribute as a team player.
- Ability to deliver quality results under high pressure deadlines in a fast-paced production environment.
- Must be capable of learning and remaining upto date on new regulatory standards and procedures.
- Ability to maintain confidentiality of data at all times.
- Must be able to read and understand all operating procedures and applicable technical information.
- Ability to comprehend and interpret regulatory guidelines and requirements.
- Ability to maintain punctual attendance, including the ability to work outside of scheduled work shift when necessary.
PHYSICAL DEMANDS: THE PHYSICAL DEMANDS LISTED BELOW ARE REPRESENTATIVE OF THOSE THAT MUST BE MET BY AN EMPLOYEE TO SUCCESSFULLY PERFORM THE ESSENTIAL FUNCTIONS OF THIS POSITION.
- Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
- Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
- Ability to constantly communicate with others.
- Ability to frequently interact and cope with irate or upset employees.
- Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
- Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
- Ability to seldom stand and/or walk for extended periods of time.
- Ability to seldom climb stairs at some locations.
- Ability to frequently push and/or pull up to twenty-five (25) pounds.
- Ability to frequently lift or carry up to twenty-five (25) pounds.
- Ability to keyboard for extended periods of time.
- Ability to function in an environment with frequent interruptions.
- Ability to deliver quality results under high-pressure deadlines in a fast-paced environment.
- Ability to demonstrate manual dexterity and eye-hand coordination.
- Ability to work beyond normal work schedule to meet critical deadlines.
- Visual acuity including close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Ability to maneuver throughout facilities to observe operations and ensure regulatory compliance.
WORK ENVIRONMENT: THE WORK ENVIRONMENT CHARACTERISTICS DESCRIBED HERE ARE REPRESENTATIVE OF THOSE AN EMPLOYEE ENCOUNTERS WHILE PERFORMING THE ESSENTIAL FUNCTIONS OF THIS POSITION.
- Primarily an office-setting environment with moderate noise levels and no direct exposure to hazardous physical substances.
Unless expressly proscribed by statute or contract, your employment with Glidewell Laboratories is “at-will”. “At-will” employment means that your employment may be terminated at any time and for any reason, with or without advance notice. Employees are also free to resign at any time.