Regulatory Affairs Specialist III in Austin, TX at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Regulatory Affairs Specialist IV

01/01/2019 – 07/06/2019 w/ benefits

Austin, TX

Pay: $25/hr + 


Responsibilities:

(Please specify % amount against each responsibility)

• (20%) Prepare submission/compliance strategy documents in line with specified timeframes.

• (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 labelling 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)

Location: Mansfield

Licenses/ Certifications:

None required, ISO Auditor certification and or RACs preferred.

EDUCATION and/or EXPERIENCE:

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.

LANGUAGE SKILLS: 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.

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.

REASONING ABILITY:

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.

Competences:

Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, ability to communicate effectively and work within international multidisciplinary team.

Physical Demands: Office work and some out of hours work will be required. Travel Requirements: 5-10%

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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