Regulatory Affairs Administrator

4 weeks ago

Suwanee, United States Femasys Inc. Full time

About Femasys Inc.

Femasys Inc. is a leading biomedical company dedicated to advancing women’s healthcare through innovative medical solutions. Our mission is to provide safe, effective, and accessible products that improve the lives of women worldwide.


Position Summary

Performs regulatory administration and compliance activities to support the Femasys worldwide regulatory activities. Works under the supervision of the Head of Regulatory to support the Femasys regulatory team.


Specific Job Functions

  • Maintain regulatory submissions for Femasys’ filing and retention.
  • Support data collection for pre-market and post-market submissions.
  • Support literature searches for regulatory intelligence to support pre-market submissions.
  • Assist regulatory team with project assignments.
  • Assist regulatory communications in keeping materials state-of-art as required by regulation.
  • Coordinate translation of materials as needed.
  • Represent the Company in a positive, professional manner with all internal and external contacts, while upholding Femasys values.


Specific Knowledge, Skills and Abilities:

  • Bachelor’s degree in sciences or engineering preferred.
  • Excellent verbal, written and interpersonal skills.
  • Computer proficiency required, ability to work efficiently with Microsoft office programs and review and edit documents and excel worksheets.
  • Strong research skills. Ability to utilize many sources for developing product information including internal, external and online.
  • Ability to effectively collaborate with team members to achieve desired outcomes and objectives.
  • Ability to multi-task, prioritize, and manage time effectively.


Physical Requirements

  • Normal office environment.


Equal Employment Opportunity Policy


Femasys, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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