Manager of Regulatory Affairs - Job # 2326

Additional Information
  • Our Client offers a fantastic working environment, a competitive salary with sizable stock options. Salary is commensurate with education and experience.
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position. Our Client is a rapidly growing start-up company based in Raleigh-Durham, NC.

Essential Duties and Responsibilities:

We are seeking to hire a Manager of Regulatory Affairs for our Client who is a successful and rapidly growing company. This incumbent will be responsible for the management of clinical affairs and with helping obtain regulatory clearance from the FDA for the many products in the pipeline. This individual combines knowledge of scientific, regulatory, and business issues to enable innovative products that are developed, manufactured, or distributed to meet required legislation.

Responsibilities will include, but are not limited to:

  • Setup regulatory policies, processes, and SOPs.
  • Evaluate regulatory risks of corporate policies.
  • Provide regulatory guidance through all stages of product development and planning.
  • Develop domestic and global regulatory strategies.
  • Monitor emerging issues in regulations and identify solutions.
  • Plan, prepare, submit, and manage applications to regulatory authorities.
  • Monitor and submit applicable reports and responses to regulatory authorities.
  • Negotiate with regulatory authorities during the development and review process to ensure submission approval.
  • Ensure compliance with product post-marketing approval requirements.
  • Review and approve marketing and promotional materials to ensure regulatory compliance.
  • Review and approve labeling to ensure compliance.
  • Review and approve required reports, supplemental submissions, and other post-marketing commitments.
  • Review change controls for level of change and consequent regulatory notification.
  • Develop, implement, and manage SOPs and systems to track and manage product associated events.
  • Lead crisis management program development and implementation.
  • Identify and present options for risk mitigation to decision makers.
  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.

Requirements:

  • Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Must have 5-7 years experience in medical products regulatory affairs. Diagnostics experience preferred.
  • Detailed knowledge of FDA 21 CFR 820 and ISO 9001/13485 and experience developing and implementing QMS systems that meet FDA requirements.
  • Regulatory knowledge of guidelines, policies, standards, practices, and requirements for diagnostic devices.
  • Familiar with GLP and GMP.
  • Preparation and submission of investigational device exemption and premarket notification applications.
  • Communicate effectively in writing and verbally including writing and editing technical documents.
  • Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Coordinate efforts in the development of relevant data to complete a regulatory submission.
  • Be able to thrive among highly intelligent and innovative individuals in a fast-paced startup environment.

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