Job Description

Job Description

Job Description

  SCOPE OF WORK SUMMARY

• Be responsible for all matters related to regulatory affairs. 
• Coordinate and facilitate US regulatory submissions and international (Outside US or OUS) regulatory registrations.
• File for and maintain CLIA waivers when needed.
• Approve product labeling, ensuring compliance with requirements.
• Participate in review, approval, and implementation of product changes.
• Provide guidance on regulatory requirements for business partners and internal customers.
• Provides advice and strategy planning with regards to compliance issues related to the FDA and OUS regulatory requirements, particularly in the USA, UK, EU, Canada, Mexico, Brazil, Australia, and Japan.
• Be responsible for US Medical Device Reporting and global vigilance reporting.
• Serve as European Person Responsible for Regulatory Compliance.
• Collaborate with Sinocare and sister company to support inter-company projects
• Provide guidance on regulatory requirements for business partners and internal customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• This is an on-site position. Remote work is not suitable for this position.
• Write, update, and file US regulatory submissions including 510(k)’s, CLIA submissions and FDA correspondence relating to issues as required
• File and update international regulatory submissions and product registrations/licensing
• Develop the timeline for US-FDA and international submissions based on the marketing and sales strategic plans
• Work with colleagues to outline data submission requirements as required
• As part of the Project Team, coordinate the collection of technical data to support submissions
• Provide global regulatory strategies for new and modified products
• Provide guidance on regulatory requirements for business partners and internal customers
• Interface with executive management regarding applicable regulations and ensure regulatory compliance
• Interface with all functional areas to advise on and assist with any compliance matters
• Provide direction and guidance in the interpretation of the FDA Medical Device Reporting, UKCA, EU Medical Device Vigilance Reporting (and other markets as required) related to product incidents and potential adverse events
• Company representative for all product/quality system regulatory agencies and Ministries of Health, to include FDA, European Notified Body, UKCA, ISO Registrar and Competent Authorities of the European Union. Remain current on regulatory requirements within these main markets. 
• Maintain product technical files / technical documentation / declarations of conformity as required within the EU, UK, Australia, etc.
• Maintain registrations in foreign countries and ensure that shipments of products are not sent to non-registered countries.
• Company representative for all quality system auditors regarding regulatory affairs compliance
• Adhere to all workplace safety laws, regulations, standards and practices
• Remain current and compliant with all training requirements
• Note – this position is not responsible for compliance with import/export laws, tariffs, patents, intellectual property, REACH, RoHs, or fraud/abuse laws. 

SUPERVISORY RESPONSIBILITY

• Manage subordinate supervisors and employees in Regulatory Affairs
• Be responsible for the overall direction, coordination, and evaluation of this functional area
• Carry out supervisory responsibilities in accordance with organization's policies and applicable laws
• Be responsible for interviewing, hiring, and training employees in regulatory affairs
• Plan, assign, and direct work
• Appraise performance, reward and discipline employees
• Addressing complaints and resolving problems

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, successful candidates should thrive in a fast-paced environment including rapidly evolving business needs. 

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.

EDUCATION and/or EXPERIENCE

• Bachelor of Science in Chemistry, Biology, Medical Technology, Engineering, or related area from an accredited four-year college or university
• Fifteen years related experience with in vitro diagnostics (IVDs) or equivalent combination of education and experience. Experience with medical devices may be able to substitute for some of the qualifications.
• Clinical laboratory experience highly desired.
• RAC certification preferred
• Strong scientifically based background

MATHEMATICAL SKILLS

• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. While this level may not be required, it is desirable when reviewing scientific documents from the R&D group. The ability to understand the concepts is more valuable than the application.

LANGUAGE SKILLS

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 

• Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to senior management, and/or public groups. Because there is no higher local regulatory position in this company, level and skills exceeding the above may be required from time to time. \

• Ability to effectively present information to senior management, and/or public groups. Because there is no higher local regulatory position in this company, level and skills exceeding the above may be required from time to time.

REASONING ABILITY

• 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 apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases
• Ability to deal with a variety of abstract and concrete variables
• Again, not required but desirable because this knowledge assists with review of both internal and external technical documentation.

PHYSICAL DEMANDS

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.

While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative to 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. The noise level in the work environment is usually moderate.

EQUAL OPPORTUNITY EMPLOYER:  PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

SAFETY RISK ASSESSMENTS (SRAs)

The following SRAs are applicable to this position:

SRA ID# 5, General Office Safety

TRAVEL

This position may require travel domestically 

DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.

Company Description

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.

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