Senior Director - Regulatory Affairs

  •  

Redwood City, CA

Industry: Business Services

  •  

11 - 15 years

Posted 58 days ago

  by    Michelle Manzon

This job is no longer available.

Job Summary

Title: Senior Director - Regulatory Affairs

Company: Biotechnology

Location: San Francisco Bay area

Type: Permanent Role

Notes: No Corp to Corp

The Senior Director, FDA Regulatory Affairs develops, communicates, executes Regulatory strategic initiatives. Responsible for supporting FDA quality system regulations such as 21CFR 801, 803, 806, 820, 21 CFR 1270 and 1271, ISO 13485, IVDR, CAMDCAS as well as any relevant international guidelines.

RESPONSIBILITIES:

· Provides direction and oversight on external regulatory projects

Strategic development and intelligence for in vitro diagnostic (IVD) and external diagnostic business and partnering activities.

· Develop and lead strategic regulatory initiatives to support growth of the company's diverse businesses such as Women's Health, Oncology and transplant.

· Drives effective collaborations with General Managers, Business Development, Medical Affairs, Clinical Affairs and Scientific Communications to ensure patient needs and clinical trial objectives are a shared focus leading to scientifically robust and compliant strategies and diagnostic product approvals.

· Is accountable for the performance and results of the FDA related Regulatory organization, including registrations, submissions, supporting clinicals, talent & organizational development, and departmental objectives.

· Develops strategies and plans to meet performance objectives of the organization.

· Manage timelines, budgets and resource allocation according to requirements of the business.

· Demonstrates ability to maintain excellent positive relationships with regulators and auditors as needed.

· Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

· Must maintain a current status on company's training requirements.

· Employee must pass post offer criminal background check

REQUIREMENTS:

  • BA/BS degree or equivalent. Advanced degree a plus. Bachelor's Degree in Business, Sciences, Engineering, Business Development, or related field requiring strategic and analytical thinking.
  • Minimum of 12-15 years Regulatory Affairs in diagnostic FDA submissions experience required.

Next Steps : Send me a quick email if you are passively or actively looking for another opportunity.Love to speak with you.

Referral Bonus: As always, we will give you a $500 referral bonus if we place someone you refer over to us! Ask for details.

Salary

$160K - $200K