Project Manager
Horizontal Talent

Our client is seeking a dedicated and detail-oriented Regulatory Affairs Project Manager to join their team at their Santa Clara, CA location. This role is integral to the company's commitment to providing high-quality, safe, and effective diagnostic products that meet customer needs and regulatory requirements.

As a Regulatory Affairs Project Manager, you will be responsible for:
- Coordinating, planning, preparing, assembling, and reviewing regulatory strategies and/or submissions to the FDA and other worldwide regulatory agencies.
- Conducting reviews of product and manufacturing changes for compliance with applicable regulations.
- Acting as a regulatory representative on core product development teams, communicating regulatory requirements and their impact.
- Reviewing and evaluating communications to ensure they adhere to applicable regulatory standards.
- Maintaining up-to-date knowledge of domestic and international medical device regulations.
- Working with cross-functional teams to support the product release process.
- Supporting all company initiatives in line with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

The ideal candidate will have:
- A Bachelor's Degree in life sciences, engineering, or another technical discipline.
- Technical or Medical Writing experience.
- Experience with Class I and II medical devices.
- Familiarity with relevant US/international regulatory requirements for medical devices, including Quality Systems standards and clinical investigations.
- Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook).
- Strong verbal and written communication skills.

Preferred qualifications include:
- 4 years of Regulatory affairs job experience in the medical device industry.
- Experience with pre-submissions, 510k submissions, Instrument/Software Submission experience, Design Planning, and On-Market Changes.
- Experience working in a broader enterprise/cross-division business unit model.

This role requires a commitment to maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. The successful candidate must pass a drug test and background check once offered the position.

Horizontal facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $41 - $48 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.