Position Summary
Manager of all aspects of Regulatory Affairs and Quality Assurance.
This job is an at-will position. Employment in this job is not for any fixed period of time, and either the Company or the employee may terminate employment at any time, with or without advance notice, and with or without cause. The Company may change the terms or conditions of employment at any time.
Essential Duties and Responsibilities
1. Technical
1.1 Interface with European parent organization to obtain necessary information required for FDA and CE compliance.
1.2 Familiar with the principles of process and product validations
1.3 Compile and/or create information for FDA regulatory submissions and technical files.
1.4 Experience in conversion process from MDD to MDR.
1.5 Prepare for and participate in FDA facility inspections, ISO audits, and third party audits.
1.6 Responsible for oversight regarding complaints and reporting MDRs.
1.7 Ensure in house training is completed according to QSR and ISO
1.8 Experienced with detailed compliance plans to FDA’s QSR regulation
1.9 Prepare and submit periodic reports, annual reports and various responses to the FDA or other regulatory agencies.

1.10 Ensure all regulatory requirements under any marketing authorization are met.
1.11 Responsible for maintaining Quality System/ISO compliance.
1.12 Responsible for coordinating the Company’s ISO audits.
1.13 Auditing (internal and external) experience required

2. Administrative
2.1 Develop labeling and ensure labeling updates as well as documentation compliance.
2.2 Administration of all company operating procedures, SOPs and document control.
2.3 Review and approve Quality documents for compliance to QSR requirements (i.e. DHR, CAPA, NCMR )
3. Travel
3.1 Some overnight travel required, both domestic and international.
4. Developmental
4.1 Responsibilities include participate in interviewing, hiring, and training employees; planning, assigning, and directing work
5. Supervisory
5.1 Manages department personnel. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
6. Additional Duties and Responsibilities
6.1 Performs such additional duties and responsibilities as may be assigned by management.
Job Requirements

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 essential functions.

1. Education/Qualifications
1.1 Minimum of 10 years experience in medical device products with a Bachelor’s degree (B.A.) from a four-year accredited college or university, or fifteen years related Quality Assurance, Regulatory Affairs and compliance experience and/or training with a BA or equivalent combination of education and experience.
1.2 Certification of the American Society of Quality (ASQ, CQM) and/or Regulatory Affairs Professional Society (RAPS, RAC-US/US/EU/Canada) and/or Project Management Institute (PMI, PM) preferred.
2. Experience
2.1. Work experience in medical device products environment.
3. Aptitude
3.1. Mathematical skills
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.
3.2. Reasoning Ability
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to gather and interpret subjective and quantitative input in the development of business analysis.

4. Operational Skills
4.1 Language
Ability to read, analyze, and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals as well as common scientific and technical journals. Ability to write routine reports and correspondence. Ability to respond to common inquiries or complaints from customers.

4.2 Technical and Computing
Proficient in Microsoft Office Suite.

5. Physical Demands
5.1 The physical demands 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.

5.2 While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and ability to adjust focus.

6. Work Environment

6.1 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.
6.2 While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and fumes or airborne particles. The noise level in the work environment is usually quiet.