Director of Regulatory Affairs Job at Connect Life Science, Sonoma, CA

UzhKRWpvL09zTWZzNStXYzQwc2FxRzlSY1E9PQ==
  • Connect Life Science
  • Sonoma, CA

Job Description

Director of Regulatory Affairs (Class III Medical Devices)

San Francisco, CA

Permanent Position

Competitive Salary & Benefits

About the company:

A mid-size and growing medical device manufacturer specializing in class III vascular devices are looking for an experienced Director of Regulatory Affairs to drive regulatory excellence in this field.

Position Overview:

They are seeking a Director of Regulatory Affairs to lead the regulatory efforts in achieving and maintaining RA compliance in US and EU markets.

As the Director of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies, ensuring compliance with global regulations, and supporting product development.

Key Responsibilities:

Regulatory Strategy: Develop and execute regulatory strategies, considering regulations and industry trends to ensure market access and compliance.

Global Compliance: Ensure compliance with FDA, EU MDR, and other international regulatory requirements for high risk medical devices. Manage submissions, including 510(k), PMA, and CE Marking.

Cross-functional Collaboration: Collaborate closely with R&D, Quality Assurance, Clinical Affairs, and others to integrate regulatory requirements into product development processes.

Regulatory Documentation: Prepare and review regulatory docs, including submissions, post-market reports, and technical documentation.

Qualifications:

• Bachelor's degree in a relevant field (Engineering, Life Science, Quality/Regulatory etc.).

• 10+ years of regulatory affairs experience in the medical device industry, with some experience in class III devices (ideally vascular).

• Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.

• Proven track record of successful regulatory submissions and approvals.

Why Join?

• Join a forward-thinking company at the forefront of vascular access.

• Make a meaningful impact on patient outcomes and lives

• Collaborate with a talented and passionate team in a dynamic work environment.

• Competitive salary and benefits package.

• Strong career prospects and opportunity to grow with the business

To apply, please submit you’re an up to date resume. We look forward to reviewing your application.

Job Tags

Permanent employment,

Similar Jobs

Surf Search

Regulatory Affairs Manager Job at Surf Search

We are looking for a talented Regulatory Affairs Manager to join our client's team and play a crucial role in bringing new products to market...  ...partners as needed to support regulatory activities.Seniority level Mid-Senior levelEmployment type Full-timeJob function... 

Springboard Healthcare

Travel Nurse RN - Interventional Radiology - $2,620 per week Job at Springboard Healthcare

 ...Springboard Healthcare is seeking a travel nurse RN Interventional Radiology for a travel nursing job in Lexington, Kentucky. Job Description & Requirements ~ Specialty: Interventional Radiology ~ Discipline: RN ~ Start Date: 05/20/2025~ Duration: 13 weeks... 

Aerotek

Assembler Job at Aerotek

 ...Description: If you're looking for a job ASAP and you have Assemblyexperience then this is theposition for you! A popular...  ...grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee... 

Sanford Health

Integrated Health Therapist or Counselor | Wahpeton Clinic Job at Sanford Health

 ...Careers With Purpose At Sanford Health and the Good Samaritan Society, we have made a system-wide commitment to the integration and collaboration of behavioral health and primary care. Join one of the largest and fastest-growing not-for-profit health systems in the... 

Pfizer

Technical Operations Specialist 2, Vaccine (Associate Degree) Job at Pfizer

 ...responsibilities as assigned by the team leader/manager.How You Will Achieve ItYou may be...  ...Qualifications:You hold a Associate Degree in a Science related field or currently enrolled...  ...assistance may be available based on business needs and/or eligibility.Sunshine Act...