Regulatory Affairs Specialist Molecular Diagnostics – Washington, DC

Do you have a deep understanding of regulatory processes in the molecular diagnostics industry? We are seeking a Regulatory Affairs Specialist to join a cutting-edge diagnostics company based in Washington, DC. In this critical role, you will help navigate complex regulatory pathways and ensure compliance with domestic and international standards. If you’re detail-oriented, science-driven, and passionate about bringing innovative diagnostics to market, this opportunity is for you.

Drive Regulatory Excellence in Molecular Diagnostics

A leading molecular diagnostics company in Washington, DC is looking for a Regulatory Affairs Specialist to support its global product development and compliance strategies. The ideal candidate will have hands-on experience with FDA submissions (510(k), PMA), knowledge of ISO and IVD regulations, and a strong background in clinical laboratory and diagnostic products. Join a team committed to transforming patient care through precision diagnostics—your regulatory expertise could help shape the future of healthcare.

Key Responsibilities of the Regulatory Affairs Specialist – Molecular Diagnostics

Regulatory Strategy & Submissions:
Develop and execute regulatory strategies for molecular diagnostic products in alignment with global requirements. Prepare, compile, and submit regulatory documents including 510(k), PMA, CE Mark technical files, and other relevant submissions to the FDA and international regulatory bodies.

Product Lifecycle Compliance:
Support regulatory compliance throughout the product lifecycle—from design and development to commercialization and post-market activities. Ensure that changes to products, labeling, and manufacturing processes meet regulatory requirements and are appropriately documented.

Cross-Functional Collaboration:
Collaborate with R&D, Quality, Clinical Affairs, and Marketing teams to provide regulatory guidance during product development. Participate in design control and risk assessment activities to ensure regulatory considerations are integrated early and consistently.

Regulatory Intelligence & Risk Mitigation:
Stay current with evolving regulations, standards (e.g., ISO 13485, IVDR), and industry best practices. Proactively assess regulatory risks and recommend mitigation strategies to support successful market access and compliance.

Labeling & Promotional Review:
Review and approve product labeling, marketing collateral, and promotional materials to ensure compliance with regulatory requirements and corporate standards. Provide input on claims development and substantiation.

Audit & Inspection Readiness:
Support internal and external audits, including FDA inspections and Notified Body audits. Prepare documentation, address regulatory findings, and ensure readiness for regulatory agency interactions.

Documentation & Recordkeeping:
Maintain accurate, organized, and audit-ready regulatory files and records. Ensure documentation is in compliance with applicable regulations and internal SOPs.

International Market Support:
Assist with global product registrations and coordinate with international regulatory consultants and distributors. Ensure compliance with country-specific requirements to enable product launch in international markets.

Training & Guidance:
Provide training and guidance to internal teams on regulatory requirements and processes. Serve as a subject matter expert (SME) in regulatory affairs to support organizational compliance and readiness.

Ethical & Regulatory Compliance:
Promote a culture of integrity and ethical conduct by ensuring all regulatory activities are carried out in compliance with applicable laws, guidelines, and company policies.

What the Client is Looking for in You

As a Regulatory Affairs Specialist – Molecular Diagnostics, the client is seeking a meticulous, knowledgeable, and proactive professional who can ensure seamless regulatory compliance and contribute to the successful launch of innovative diagnostic products. You should possess strong regulatory expertise, exceptional attention to detail, and a collaborative mindset to support cross-functional teams in a dynamic and fast-paced healthcare environment.

Expertise in Molecular Diagnostics and Regulatory Submissions

The ideal candidate will have hands-on experience with regulatory submissions such as 510(k), PMA, and CE Mark technical documentation, specifically within the molecular diagnostics or IVD industry. You should be well-versed in U.S. FDA regulations, IVDR (EU), and other international requirements, with a demonstrated ability to manage submission timelines, respond to agency queries, and support post-market regulatory needs.

Strong Analytical and Strategic Mindset

The client values professionals who can think critically and strategically about regulatory challenges. You should be able to assess risks, interpret complex regulatory requirements, and provide actionable guidance to development teams. Experience in influencing product development with regulatory foresight is highly valued.

Cross-Functional Communication Skills

You must be a strong communicator, capable of clearly translating regulatory requirements to internal stakeholders including R&D, Quality, Clinical, and Marketing teams. The ability to foster alignment across departments and guide cross-functional initiatives is essential to this role.

Attention to Detail and Process Orientation

Regulatory compliance demands exceptional accuracy. The client seeks someone who can consistently produce high-quality documentation, manage detailed regulatory files, and ensure audit-readiness. Familiarity with design control documentation, labeling review, and regulatory change management is expected.

Global Regulatory Awareness

In today’s expanding diagnostics market, knowledge of global regulatory frameworks is critical. The client is looking for someone who understands international submission processes, country-specific registration requirements, and how to coordinate with local regulatory partners or consultants worldwide.

Proactive and Collaborative Work Ethic

You should be a self-starter who takes ownership of your work while thriving in a team-oriented culture. The ability to proactively identify regulatory risks, propose solutions, and contribute to the company’s mission of advancing diagnostics is highly valued.

Commitment to Ethical Standards and Compliance

A strong understanding of ethical regulatory practices and a commitment to integrity are essential. The client values candidates who prioritize compliance, contribute to a culture of quality, and help uphold the company’s reputation with regulators and healthcare partners alike.

FAQs About the Role – Regulatory Affairs Specialist – Molecular Diagnostics

1. What are the key responsibilities of the Regulatory Affairs Specialist in this role?
As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting regulatory documentation for domestic and international markets (including FDA, IVDR, and other global regulatory bodies). You will collaborate with cross-functional teams to ensure product compliance from development through post-market, maintain regulatory files, support audits, and provide guidance on labeling, technical documentation, and regulatory strategy.

2. What qualifications and experience are required for this position?
The ideal candidate should have a Bachelor’s or Master’s degree in a life science, biomedical, or related field, along with 3–5+ years of regulatory affairs experience in the molecular diagnostics or in vitro diagnostics (IVD) industry. Experience with FDA submissions (510(k), PMA), EU IVDR, and global registration processes is highly desired. Regulatory Affairs Certification (RAC) is a plus but not required.

3. What skills are essential to succeed in this role?
Strong analytical thinking, attention to detail, and the ability to interpret complex regulatory guidelines are essential. Excellent written and verbal communication skills are needed to develop submission materials and collaborate across departments. You should be organized, deadline-driven, and capable of managing multiple projects in a dynamic, fast-paced environment.

4. What regulatory challenges might I face in this position?
You may face challenges such as navigating evolving global regulatory requirements (e.g., transitioning from IVDD to IVDR in the EU), responding to agency queries in a timely manner, and ensuring documentation accuracy under tight deadlines. Staying updated on regulatory changes and ensuring internal compliance processes align with external standards will be key to success.

5. What kind of impact will I have on the company’s success?
You will play a critical role in enabling the company to bring safe, effective, and compliant diagnostic products to market efficiently. Your expertise will directly influence regulatory approval timelines, global market access, and the company’s ability to innovate within a compliant framework. Your contributions will help safeguard product quality and uphold the company’s reputation with regulatory authorities.

6. What is the team and work environment like?
The company values a collaborative, quality-focused, and innovation-driven work culture. You’ll work closely with R&D, Quality Assurance, Clinical, and Marketing teams in a supportive environment that encourages continuous learning and professional growth. The role offers opportunities to take ownership of regulatory initiatives and make a visible impact on the organization.

What Remuneration Can You Expect from This Job?

As a Regulatory Affairs Specialist – Molecular Diagnostics, you can expect a competitive compensation package that reflects your specialized expertise, experience, and the vital role you play in ensuring regulatory compliance and product success. The remuneration typically includes the following components:

1. Base Salary
The annual base salary for a Regulatory Affairs Specialist in the molecular diagnostics or in vitro diagnostics (IVD) industry typically ranges from $85,000 to $130,000, depending on experience, qualifications, geographic location, and company size. Senior specialists or those with niche regulatory expertise (e.g., FDA submissions or IVDR) may command higher salaries.

2. Performance-Based Bonuses
Many employers offer annual performance bonuses tied to both individual and company goals. These may include metrics such as submission success rates, time-to-market improvements, audit readiness, and overall regulatory compliance. Bonuses usually range from 10% to 20% of the base salary, with higher incentives possible for exceptional performers.

3. Equity or Stock Options (for Mid to Large Companies)
Some employers, particularly startups or mid-to-large biotech firms, may offer stock options or restricted stock units (RSUs) as part of the total compensation package. This equity-based incentive aligns your contributions with the company’s long-term success and can significantly enhance your financial rewards as the company grows.

4. Comprehensive Benefits Package
You can expect a robust benefits package that typically includes:

Health, dental, and vision insurance
401(k) plan with company match or pension contribution
Paid time off (PTO), vacation, and sick leave
Life and disability insurance
Employee wellness programs and mental health support
Tuition reimbursement or continuing education stipends

5. Relocation Assistance & Signing Bonuses
For high-demand candidates or those moving to a new location, companies may offer relocation assistance and/or a signing bonus ranging from $5,000 to $20,000, depending on the company’s policies and the candidate’s seniority level.

Total Compensation Potential

When combining base salary, bonuses, and other incentives, total annual compensation for a Regulatory Affairs Specialist in this field can range from $95,000 to over $150,000, with further growth potential as you take on leadership roles or specialize in global regulatory strategy.

How to Apply

If you are a regulatory professional with deep expertise in molecular diagnostics or in vitro diagnostics (IVD) and a passion for navigating complex regulatory pathways, we invite you to apply for the Regulatory Affairs Specialist – Molecular Diagnostics role.

This is an exciting opportunity to play a critical role in ensuring product compliance, securing global market access, and driving innovation in a rapidly evolving diagnostics landscape.

To apply, please submit your updated resume along with a cover letter that highlights your experience in:

Regulatory strategy and submission preparation (FDA, EU IVDR, Health Canada, etc.)
Technical documentation for diagnostic assays or devices
Cross-functional collaboration with R&D, QA, and manufacturing teams
Responding to regulatory audits or queries
Keeping up with evolving global regulatory requirements

Your ability to contribute to product lifecycle management, support timely product approvals, and ensure adherence to regional and international regulatory standards will be key to success in this role.

Apply today to join a high-impact team at the forefront of diagnostic innovation!

For more information or to explore similar opportunities in regulatory affairs and diagnostics, visit our Molecular Diagnostics Recruiting Experts Page.

Job Category: Molecular Diagnostics

Job Type: Full Time

Job Location: Washington

Regulatory Affairs Specialist Molecular Diagnostics – Washington, DC