Principal Regulatory Affairs Specialist

Elixir Medical Corporation; Milpitas (CA); On-site; USD 115,000 - 150,000; Full time

Job summary

Elixir Medical Corporation seeks a Regulatory Affairs Specialist to support global regulatory applications and ensure compliance with product development protocols. The qualified candidate will have a Bachelor's in Engineering or Science and at least 5 years of regulatory experience in medical devices. This is a full-time position offering a competitive salary and benefits in a dynamic industry.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• 5+ years of regulatory work experience in the medical device industry.
• Experience with European regulations (MDR) is required.
• Experience leading major international regulatory submissions.

Responsibilities

• Prepare and submit global regulatory applications.
• Provide regulatory guidance throughout research and development.
• Monitor regulatory agency activities relevant to the company.

Skills

Regulatory Compliance

Risk Analysis

Strategic Guidance

Interpersonal Skills

Attention to Detail

Education

Bachelor's degree in Engineering or Science

Tools

Microsoft Office

Job description

Elixir Medical Corporation provided pay range

This range is provided by Elixir Medical Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$115,000.00/yr - $150,000.00/yr

MAJOR DUTIES AND RESPONSIBILITIES

Responsibilities will include, but not be limited to:

• Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the company’s strategic objectives
• Formulate and implement regulatory strategy, provide guidance, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs
• Work directly and interactively with cross functional teams during product development and production phases interpreting regulations, analyzing risks, and providing direction on test strategies and reviews thereof. Define strategies to mitigate risks
• Provide regulatory guidance to company personnel throughout the research and development and production processes
• Prepare and deliver effective presentations for external and internal audiences
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company
• Provide strategic guidance and regulatory support for the design and approval of nonclinical studies and clinical trials
• Provide regulatory support for post market activities/requirements

QUALIFICATIONS

Experience

• Bachelor's degree in Engineering or Science field
• 5+ years of regulatory work experience in the medical device industry (3+ in Class III Risk Devices)
• Prior experience with European regulations (MDR)
• Significant experience in leading and preparing major international regulatory submission projects and supportive amendments or supplements, and interfacing with regulatory authorities
• Experience in FDA submissions (clinical and market approvals)
• Experience leading and influencing project teams to attain group goals
• Experience in analysis, interpretation and extraction of important concepts from engineering/technical specifications and data, scientific information, international standards and government regulations
• Experience in writing reports and complex submissions (i.e., for PMDA, MFDS, TGA, ANVISA, CE Technical Files, etc.).
• Background in reviewing advertising and promotion materials
• Background in post market regulatory requirements
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel, including medical, scientific and manufacturing staff
• Excellent attention to detail and organizational skills
• Proficient at Microsoft Office suite of software tools

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning and Other

• Industries

  Medical Device

Referrals increase your chances of interviewing at Elixir Medical Corporation by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Get notified when a new job is posted.

Sign in to set job alerts for “Regulatory Affairs Specialist” roles.

Continue with Google Continue with Google

Continue with Google Continue with Google

San Jose, CA $80,000 - $90,000 3 months ago

Regulatory Affairs Specialist - Shockwave Medical

Union City, CA
$110,000.00
-
$120,000.00
1 week ago

Regulatory Affairs Specialist I - Heart Failure (on-site)

Pleasanton, CA
$72,100.00
-
$114,700.00
2 days ago

Sunnyvale, CA
$80,900.00
-
$128,800.00
1 week ago

San Jose, CA
$97,600.00
-
$165,200.00
11 hours ago

Regulatory Affairs Specialist - (NMPA/CFDA)

Sunnyvale, CA
$97,600.00
-
$165,200.00
11 hours ago

Mountain View, CA
$75,000.00
-
$90,000.00
2 weeks ago

Regulatory Affairs Specialist - Shockwave Medical

Santa Clara, CA
$74,000.00
-
$138,000.00
4 hours ago

Operational & Regulatory Compliance Lead

Redwood City, CA
$160,000.00
-
$200,000.00
5 days ago

Regulatory Affairs Specialist - Pleasanton, CA

Pleasanton, CA
$115,000.00
-
$125,000.00
2 weeks ago

Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

Senior Regulatory Affairs Specialist -Vascular (on-site)

Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

Santa Clara, CA $89,000 - $165,600 4 hours ago

Senior Regulatory Affairs Specialist – Vascular (on-site)

Regulatory Affairs Manager – Heart Failure (on-site)

Pleasanton, CA $112,000 - $224,000 1 week ago

Sunnyvale, CA $80,000 - $140,000 6 months ago

Regulatory Affairs Manager – Vascular (on-site)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.