Sr Regulatory Affairs Specialist (Remote) - Shockwave

Freddie Mac; Santa Clara (CA); Remote; USD 120,000 - 166,000; Full time

Job summary

A leading company in healthcare innovation seeks a Regulatory Affairs professional in Santa Clara, CA. The role involves developing regulatory strategies, ensuring compliance, and preparing submissions for medical devices. Ideal candidates hold a Bachelor’s degree with desired experience in regulatory affairs, and are organized, communicative, and capable of managing multiple projects in a collaborative fast-paced environment.

Benefits

Comprehensive employee benefits

Flexible remote work options

Generous time off policies

Opportunity for annual performance bonuses

Participation in long-term incentive program

Qualifications

• Minimum 5 years of regulatory affairs experience in medical device sector.
• Experience with 510(k) and PMA submissions.
• Strong understanding of US and EU regulatory policies.

Responsibilities

• Collaborate to meet regulatory requirements for medical devices.
• Prepare high-quality regulatory submissions on time.
• Negotiate with regulatory authorities.

Skills

Regulatory affairs experience

Verbal communication skills

Written communication skills

Knowledge of regulatory guidelines

Education

Bachelor's degree in a relevant field

Master's degree or PhD (preferred)

Tools

MS Word

Excel

Adobe

PowerPoint

Job description

Employer Industry: Healthcare Innovation and Medical Technology

Why consider this job opportunity:
- Salary up to $165,600
- Opportunity for annual performance bonuses based on individual and corporate performance
- Comprehensive employee benefits including medical, dental, vision, and life insurance
- Participation in the company's long-term incentive program
- Generous time off policies, including vacation, sick time, and personal time
- Flexible remote work options available

What to Expect (Job Responsibilities):
- Collaborate with various departments to meet regulatory requirements for medical devices
- Develop and outline regulatory strategies in alignment with business priorities
- Review and approve documentation for regulatory submission filing
- Prepare and submit high-quality regulatory submissions on time for the US and EU
- Communicate application progress and negotiate with regulatory authorities

What is Required (Qualifications):
- Minimum 5 years of regulatory affairs experience in the medical device industry or equivalent work experience
- Bachelor's degree in a relevant field; Master's degree or PhD preferred
- Working knowledge of domestic and international regulatory guidelines and policies
- Experience with pre- and post-market medical device submissions such as 510(k) and PMA
- Strong verbal and written communication skills with diverse audiences

How to Stand Out (Preferred Qualifications):
- Some medical device software engineering background or experience
- Experience with international regulatory filings (e.g., TGA, Health Canada)
- Ability to work collaboratively in a fast-paced environment
- Highly organized with the ability to manage multiple projects simultaneously
- Proficiency in MS Word, Excel, Adobe, and PowerPoint

#HealthcareInnovation #MedicalTechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay

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