The incumbent possesses knowledge of regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision.
Domestic and international travel may be required up to 25% of time.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Prepare global regulatory submissions such as; 510(k), PMA, for new and modified devices.
2. Work closely with teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in US market.
3. Communicate with FDA regarding submissions.
4. Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.
5. Review package inserts (labeling) and promotional materials to insure compliance with FDA requirements.
OTHER JOB FUNCTIONS:
1. Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary.
2. Assist in the development of project specific and departmental budgets.
3. Represent Company in industry associations, standards organizations, and corporate regulatory/clinical group meetings.
4. Other duties as assigned.
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, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Experience & Knowledge Essential EDUCATION and/or EXPERIENCE:
Bachelor’s or Master’s degree in Engineering or life sciences preferred, but other degrees may be considered.
The candidate should have a minimum of 5 years of regulatory submissions experience in the medical device industry specifically with US FDA submissions. Wound, and reconstructive device experience is desired.
Extensive knowledge of FDA regulations required.
Excellent English written and verbal communication skills including presentation skills, Microsoft Office application skills, self motivated, attention to detail, able to prioritize and manage multiple projects. Able to lead projects with minimal supervision.
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents.
Ability to respond to inquiries and complaints from customers and regulatory agencies.
Ability to write detailed technical regulatory submissions, reports and business correspondence.
Ability to effectively present information to other employees, management and regulatory agencies.
Ability to compute ratio, percent and draw and interpret raw data into graphical representations.
Ability to convert English units into metric units and vice versa.
Ability to comprehend and apply principles of algebra, statistics, calculus and mathematical operations used in various engineering and clinical analysis.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essentials function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires sitting, talking or listening, more than 2/3 of the time. Walking or standing less than 1/3 of the time. Use of hands to use computer or write documents less than 2/3 of the time.
Ability to travel by air and motor vehicle both domestically and internationally required. Some overnight travel required. Searching for, lifting and carrying records weighing up to 25 pounds less than 1/3 of the time.
Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires working most of the time in an office setting.
• (20%) Prepare submission/compliance strategy documents in line with specified time frames.
• (20%) Supports the generation of technical documentation and the writing and compilation of technical files.
• (20%) Works with cross functional teams – with senior support - to deliver supporting documentation (IFU, DHF, CER etc.)
• (10%) Reviews and approves labeling and instruction for use.
• (20%) Supports and implements the global market change program
• (5%) Supports Technical File Audits
• (5%) Help maintain licenses, manage legacy TF updates (removal of SKUs as they transition to MDR)
Licenses/ Certifications: ISO Auditor certification and or RACs preferred. EDUCATION and/or
Bachelor Degree in Engineering or 2 years' experience in the medical device industry;
or BA or BS in Life Science, nursing, medical technology or related discipline with prior experience or 3 years in the medical industry.
Knowledge or current EU regulations is preferred.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence.
Ability to effectively present information and respond to questions from groups of managers clients, customers and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, ability to communicate effectively and work within international multidisciplinary team.
Office work and some out of hours work will be required.
Travel Requirements: 5-10%