Regulatory Affairs Specialist

Genesis10 is currently seeking a Regulatory Affairs Specialist with our client in their Mountain View, CA location. This is a 3 month + contract and hybrid remote position.

Summary:

• The client Health is seeking a Regulatory Affairs Specialist to join our team as we ensure our adherence to global medical device regulations and standards.
• Our aim is to build health technologies that improve lives and have a positive social impact.
• Our team includes experts who are leveraging expertise in AI, hardware, products, and more to solve the big challenges in healthcare to help people lead healthier, more productive lives.
• This team works closely with other groups within the client.

Responsibilities:

• Develop strategies and submissions for complex, regulated, medical device products to gain approvals for commercial distribution and clinical research in various geographies.
• Work with the product team to develop a global market strategy for regulatory authorization plans, including product requirements, clinical trials and regulatory communications and submissions. Communicate status updates, issues and potential issues regarding regulatory plans, regulations and standards to key stakeholders.
• Ensure that product documentation and promotional content are reviewed and edited to adhere to regulatory requirements.
• Ensure that post-market surveillance obligations are compliant.
• Working with cross-functional product and research teams to develop regulatory strategies to meet business objectives in a compliant manner.
• Prepare plans, reports and documented evidence for product development and research projects to demonstrate adherence to regulatory requirements.
• Support creation and review of external content (blogs, research papers, presentations) to assure that company statements and claims are compliant with global regulatory requirements.

Requirements:

• 7+ years of experience in medical device regulatory affairs in global markets.
• Experience in US and international regulation of SaMD.
• Experience in the preparation/clearance of FDA 510(k) submissions and international medical device submissions.
• Bachelor's degree in health/physical sciences, engineering or related field.
• Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

Desired:

• Advanced degree or professional certification in medical device regulatory affairs.
• Knowledge of clinical research methodology and providing advice to teams conducting clinical evaluations and investigations in accordance with the ISO 14155 and Google Cloud Platform.
• Experience in medical device standards development and compliance (e.g. AAMI, IEC, ISO).
• Experience with the EU MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations.
• Experience with standalone SaMD mobile apps, wearable applications, or other consumer facing health solutions.
• Experience negotiating with international market regulators such as TGA, PMDA and ANVISA.

Pay rate range: $112.35 - $145.43 hourly

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF)
• Remote opportunities available

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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