Senior Regulatory Affairs Specialist

1 day ago

Martinez, California, United States Biocare Medical Full time
Job Title: Senior Regulatory Affairs Specialist

Biocare Medical is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and maintaining our company's quality system.

Key Responsibilities:
  • Supports product development and completes global regulatory submissions in connection with the marketing of products.
  • Maintains knowledge and understanding of applicable regulations and harmonized standards.
  • Participates in internal and external audits and inspections, including follow-up activities, as required.
  • Provides regulatory guidance and inputs to departments or development project teams regarding design and development, change control, testing, labeling, and marketing of products.
  • Performs and maintains registration and product listing/licensing with regulatory agencies, and renewal of pertinent business licenses, as required.
  • Reviews and approves product labeling such as product labels, data sheets, user manuals, safety data sheets, and promotional materials.
  • Participates in conducting company-wide compliance training, as needed.
  • Generates Technical Documentation, where required, including but not limited to preparing regulatory plans, clinical evaluations, and post-market reports.
  • Provides regulatory support and participates in CAPAs as needed.
Requirements:
  • BS/BA Degree with five (5) years working in pharmaceutical or medical device industry or MS Degree with 3 years of relevant experience.
  • Strong oral and written communication skills.
  • Willing to set and drive aggressive project timelines.
  • Capable of strategic thinking and proposing solutions to regulatory problems.
  • Attention to detail and good organizational skills.
  • Problem solving and investigative skills.
  • High level of reading comprehension.
  • Demonstrates independent judgment within broadly defined policies and ability to lead multiple projects.
  • Strong computer and internet research literacy.
  • Knowledge of FDA/EMEA, ISO/GMP.
Work Environment:

Onsite - Pacheco, CA

8 a.m. to 5 p.m. Monday - Friday. This position may require working extended weekday or weekend hours depending on business needs.

Compensation:

$120,000 - $130,000 annually

Full-Time Positions Offer

  • Company Sponsored Health Insurance - medical, dental, vision
  • Company Sponsored Life Insurance
  • Voluntary Benefits
  • Retirement plan - 401(k)
  • PTO
  • Paid Holidays

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world.

Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

All inquiries strictly confidential.

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