Regulatory Affairs Manager

Location
Burlingame, California, United States
Posted
May 29, 2021
Ref
4494114003
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Inflammatix seeks a Regulatory Affairs Manager to collaborate on multiple submissions and manage a nascent Regulatory Affairs team. This position reports to the Vice President of Regulatory Affairs and Quality Assurance. The Regulatory Affairs Manager will direct and oversee regulatory activities for new and existing products to ensure compliance with regulatory requirements for submissions, registrations, etc.

POSITION SUMMARY:
  • Develop and implement strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
  • Ensure timely preparation of organized and scientifically valid applications. Provide expertise in translating regulatory requirements into practical, workable solutions
  • Provide input into post-market activities, including complaint handling, adverse event reporting, etc.

PRIMARY RESPONSIBILITIES:
  • Manage regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products.
  • Manage the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation of submissions to achieve timely and cost-effective clearance/approval. Provide information for maintaining registrations and listings.
  • Monitor and assess Regulatory developments (e.g., Federal Register publication/notices, FDA guidelines, etc.) related to the Company's products.
  • Review product labeling to ensure conformance with Regulatory requirements and/or approved product claims.
  • Support internal and external audits; collaborate with Quality Assurance to coordinate strategy and provide responses to audit requests and inquiries

MINIMUM QUALIFICATIONS:
  • Bachelor's degree in a physical or life science.
  • A minimum of 8 years regulatory affairs experience in the medical device industry
  • Knowledge of ISO 13485:2016 and 21 CFR Part 820
  • Knowledge of IVDD and IVDR requirements
  • 510(k) submission experience

PREFERRED QUALIFICATIONS:
  • In addition, medical device submissions experience and IVD experience is strongly preferred.
  • A minimum of one year experience in a managerial role
  • Broad knowledge of and experience with US, EU, and Rest-of-World medical device
  • Regulatory Affairs certificate from RAPS or other organizations

KNOWLEDGE, SKILLS, AND ABILITIES:
  • High ethical standards and integrity
  • Ability to work well independently and in a team environment, interact productively, and effectively with peers, management and third parties
  • Proficiency with MS Office including Word, Excel, and PowerPoint
  • Ability to maintain a high level of confidentiality
  • Use resources effectively and reasonably
  • Excellent verbal and written communication skills

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position
  • Compensation: Competitive and commensurate with experience; equity package
  • Benefits: Medical, dental, and vision; 401(k) and more

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic pa rtner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.