Regulatory Affairs Specialist II

With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities, Notified Bodies and other regulatory agencies on defined matters to achieve approval to sell Celera products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.

IMPACT:

Successful performance contributes to the receipt of and maintenance of regulatory approvals to sell Celera products throughout the world.

JOB RESPONSIBILITIES:

1. Participate on project teams as regulatory or as RA/QA/CA representative.

2. Develop plans to receive approvals to sell products identified in the marketing sales plan.

3. Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.

4. Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.

5. Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.

6. Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.

7. Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.

JOB REQUIREMENTS:

- To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or CONFIDENTIAL AND PROPRIETARY INFORMATION.

EDUCATION AND/OR EXPERIENCE:

- Requires knowledge and skills normally acquired through the successful completion of a B.S. or M.S. degree in a scientific discipline or equivalent with a minimum of 5 years experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVD experience required. Experience with IVD PMA submissions preferred.

LANGUAGE SKILLS:

- Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.

MATHEMATICAL SKILLS:

- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.

REASONING ABILITY:

- Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to handle multiple projects and prioritize tasks/deliverables. Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form.

LICENSES, CERTIFICATES, REGISTRATION:

- Regulatory Accreditation Certificate desirable.

OTHER KNOWLEDGE, SKILLS AND ABILITIES:

Demonstrated working knowledge of submissions principles and good writing skills required.

POSITIONS SUPERVISED:

DIRECT:

None

INDIRECT:

None

SUPERVISION RECEIVED:

Receives limited supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

INTERFACE WITH OTHERS:

INTERNAL:

Development, Materials, Manufacturing, Quality Control, Quality Assurance, Instrument Systems, Marketing and Technical Support organizations.

EXTERNAL:

Regulatory agencies, customers and marketing partners

PHYSICAL REQUIREMENTS:

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.

Most duties are performed while sitting at a desk, (i.e., operating a computer or typewriter, using a telephone, or writing and analyzing data and/or reports). Walking or standing within the office area may be required for the operation of other office equipment and for meetings.

WORKING ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier and telephone. The noise level in the work environment is usually moderate to quiet.