Our team is growing, and we currently have an immediate opening for a Senior Regulatory Affairs Specialist Title: Senior Regulatory Affairs Specialist Location: Remote or Hybrid (Cleveland, Ohio) Reports to: Head of Regulatory Affairs (Senior Director / VP, Regulatory Affairs) Job Description: This position will support and execute regulatory activities for blood-based in vitro diagnostic (IVD) products for early cancer detection and other clinical conditions/indications, including the preparation, review, and maintenance of regulatory submissions and technical documentation across the product lifecycle. The Senior Regulatory Affairs Specialist will work closely with cross-functional teams (Clinical Operations, Legal and Compliance, IVD Test Development, Quality, Manufacturing, and external consultants) to ensure compliance with applicable U.S. and international regulatory requirements, including FDA and IVDR. This role is hands-on and execution-focused, supporting both pre-market and post-market regulatory obligations under the direction of senior regulatory leadership. Essential Duties and Responsibilities - Support the development and execution of regulatory strategies for new and existing products throughout the product lifecycle.
- Prepare, compile, review, and maintain regulatory submissions and documentation, including but not limited to 510(k)s, PMAs, PMA supplements, amendments, annual reports, and IVDR Technical Documentation.
- Maintain product approvals and support required notifications, supplements, amendments, listings, and post-approval reporting activities on a domestic and international basis.
- Support regulatory activities related to product development, design changes, and manufacturing or process changes, including coordination with IVD Test Development, Clinical Operations, and Quality Assurance teams.
- Collaborate cross-functionally with internal teams to prepare high-quality regulatory submissions and responses to regulatory agency questions, ensuring compliance with regulatory requirements and timelines.
- Support post-market regulatory activities, including PMS, vigilance reporting, and maintenance of regulatory records.
- Monitor and track changes in applicable regulatory requirements and communicate relevant updates to internal stakeholders.
- Assist in the development, implementation, and maintenance of regulatory policies, procedures, and templates.
- Support interactions with regulatory authorities and Notified Bodies as directed.
- Review technical and scientific documentation to ensure regulatory consistency and compliance.
- Provide regulatory guidance to internal stakeholders on assigned projects.
- Perform all other duties as assigned.
Qualifications/Requirements - Bachelor’s degree in science, engineering, or medical-related field required.
- RAC certification or progress toward certification preferred.
- 5+ years of regulatory affairs experience in the medical device or IVD industry.
- Demonstrated experience supporting FDA submissions (e.g., 510(k), PMA, PMA supplements) and/or international regulatory documentation.
- Working knowledge of applicable regulatory frameworks, including FDA device regulations, ISO 13485, 21 CFR 820, CLIA and IVDR.
- Exceptional attention to detail with the ability to ensure accuracy, completeness, and consistency across complex regulatory documentation.
- Excellent technical writing and editing skills, with demonstrated experience preparing, reviewing, and refining regulatory submissions, reports, and formal correspondence with regulatory authorities.
- Advanced proficiency in Microsoft Word, including use of styles, formatting controls, document templates, tracked changes, cross-references, tables of contents, and management of large, complex technical documents.
- Experience supporting preparation and maintenance of technical documentation, regulatory reports, submission dossiers and regulatory correspondence.
- Ability to critically review and contribute to technical and scientific documentation.
- Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams.
- Proven ability to manage multiple projects and priorities in a collaborative environment.
- Detail-oriented with strong organizational, document management, and version-control discipline.
Physical Requirements/ Working Conditions/Equipment Used: - Offices reachable by elevator but should be able to climb stairs in case elevator out
- General office noise and HVAC
- Ability to sit and/or stand and operate a computer and other technology-related lab equipment throughout course of day
- May be exposed to hazardous chemicals, biohazards, etc.
------------------------------------------------------ Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: - 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
- 100% Employer-paid Dental & Vision for entire family
- No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
- 4% retirement contribution Employer match
- Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
- Paid Family Leave Program
- Generous PTO plan & holiday program
- Flexible work schedule & lucrative employee referral program
- Salary range may vary by work state/geographical region/territory
- Easy to get to office location with newly built-out office space
- Free coffee, snacks and other goodies all day long
Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
|
