Address
Form of work
SalaryObjective
Under general direction, will prepare regulatory submission documents for FDA and International filings and provide regulatory assessment of manufacturing changes and marketing promotional materials.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Secure and maintain all establishment licenses, registrations and listings, including US Wholesale Drug Distribution Licensing.
- Drive International Product Registration projects to completion.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Prepare regulatory submissions including 510(k) submissions; assist in the preparation of IDE and PMA.
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
- Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
- Provide regulatory documentation and product information to agents and distributors to support worldwide sales. Maintain FDA Certificate to Foreign Government.
- Prepare responses to customers, trading partners and other agency requests for information, such as product data, written regulatory statements, surveys, and questionnaires
- Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.
- Provide review of general internal Quality System compliance to regulations.
- Ensure the appropriateness of regulatory standards referenced within DenMat Quality System.
- Monitor current and pending legislation relating to regulatory requirements and assess new developments affecting the company’s regulatory requirements. Update internal procedures to reflect new regulatory standards as required.
- Ensure compliance with product post-marketing approval requirements.
- Submit Product Complaints System reporting including FDA MDR's, EU Vigilance, and Canadian Medical Device reporting.
- Assist in product-associated events and recall related activities. Ensure product safety issues and product-associated events are reported to regulatory agencies. Assist in the development and implementation of SOP’s and systems to track and manage product-associated events.
- Provide cross functional or new product development teams with guidance to meet regulatory requirements and to support product filings.
- Assist QA in creation and maintenance of CE Technical Files, Clinical Evaluation Reports (CER), Essential Requirements Reports (ERR), etc.
- Maintain Declarations of Conformity.
- Review proposed document changes to determine level of impact and consequent submission requirements, including Notified Body Notices of Change.
- Provide regulatory input for and appropriate follow-up to inspections and audits. Accompany inspection team(s) as required.
- Assist in the development of departmental policy and regulatory strategy.
- Develop and maintain productive and effective relationships with regulatory authority reviewers, peers, and superiors.
- Demonstrate a high standard of work ethics and professionalism to regulatory authority reviewers, peers, and superiors at all times.
- Represent the company in a positive and supportive manner at all times.
Additional Duties and Responsibilities include the following. Other duties may be assigned.
- Travel to attend conferences, seminars, or for other business as required.
- Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations.
- Stay abreast of relevant information pertaining to new developments in regulatory affairs by maintaining contact with other professionals in the field (e.g., professional associations and regulatory agencies).
- Review work reports, papers, and other records prepared by others for clarity, completeness, accuracy, and conformance with company policies and federal regulations.
- Report on departmental activities to senior management.
- Other projects as assigned.
Supervisory Responsibilities
This position has no supervisory responsibilities.
Education and/or Experience
Bachelor's degree (B.A./B.S.) from four-year college or university in a scientific field; and three to five years related experience; or equivalent combination of education and experience. Previous medical device regulatory experience is desirable.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.
Language Skills
Ability to read, analyze, and interpret complex scientific and regulatory publications/documents. Ability to respond effectively to complex regulatory issues and write technical and regulatory reports, documents, business correspondence, and procedures. Ability to respond to questions or complaints from managers, customers, other employees of the organization and regulatory and government agencies.
Mathematical Skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Computer Skills
Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
Certificates, Licenses, Registrations
Regulatory Affairs certificate is desirable.
Knowledge, Skills, and Abilities
Knowledge of FDA QSR’s and U.S. Food, Drug, and Cosmetic Act as amended.
Knowledge of Canadian Medical Device Requirements
Knowledge of European Union Medical Device Requirements
Knowledge of ISO 13485
Knowledge of medical device manufacturing or a related field.
Skill in demonstrating a professional phone manner.
Ability to work independently, take initiative and make decisions within department/company guidelines.
Ability to demonstrate excellent negotiation, organizational, interpersonal, relationship building, and reasoning skills.
Ability to establish and maintain moderately complex documentation systems.
Ability to communicate effectively, orally and in writing, with employees and other internal and external contacts.
Ability to be flexible in changing daily workload priorities as directed.
Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
Ability to coordinate and synchronize multiple projects.
Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.
Ability to demonstrate leadership in job performance by example.
Ability to travel for business, including overnight stays.
Ability to use MSWord, Excel, FileMaker Pro and PowerPoint, and operate various office equipment such as computer, printer, phone, and fax. Experience with data analysis/statistical such as MiniTab or equivalent.
Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of the job, the employee is regularly required to stand, walk, sit, talk, hear, and use hands repetitively. The employee is occasionally required to use hands to finger, handle, or to feel; to use hands to grasp; to use extended reach with hands; to use fine dexterity with both hands; and lift or move up to 10 lbs. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet.
The posted range for this position is $66,500-$95,000 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
DenMat offers a complete benefits package, including medical/dental/vision/Rx, Life, 401(k) with matching, 10 paid company holidays, vacation and sick time, bereavement, EAP, and employee discounts.
DenMat participates in E-Verify.
DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.
