IVD Regulatory Compliance Analyst – Philadelphia, PA

Are you an expert in In Vitro Diagnostic (IVD) regulatory compliance with a passion for ensuring quality and safety in medical devices? We are looking for an IVD Regulatory Compliance Analyst to join our team in Philadelphia, PA. This is an exciting opportunity to play a crucial role in maintaining and enhancing regulatory processes for IVD products in a rapidly evolving healthcare environment. If you have experience navigating complex regulations and a strong commitment to ensuring compliance, this position is the perfect fit for you.

Lead Regulatory Excellence in IVD Products

As an IVD Regulatory Compliance Analyst, you will be at the forefront of managing regulatory strategies for a leading healthcare organization. Your primary responsibility will be ensuring that all IVD products comply with FDA, ISO, and international regulatory standards. You will work closely with cross-functional teams to navigate the regulatory landscape, ensuring that products meet the highest safety and quality standards. If you’re ready to make an impact in the IVD space and contribute to the advancement of healthcare, we want you to be part of our team.

Key Responsibilities of the IVD Regulatory Compliance Analyst – Philadelphia, PA

Regulatory Strategy & Compliance: Develop and implement regulatory strategies to ensure In Vitro Diagnostic (IVD) products meet FDA, ISO, and international regulatory standards. Stay updated on evolving regulations and ensure that all products comply with the necessary requirements throughout their lifecycle.

Documentation & Submission Management: Prepare and review regulatory submissions to regulatory bodies, ensuring that all documents are accurate, timely, and complete. Work closely with cross-functional teams to ensure regulatory submissions meet required guidelines and timelines.

Cross-Functional Collaboration: Collaborate with internal departments such as R&D, quality assurance, and operations to ensure regulatory compliance is integrated throughout product development, manufacturing, and post-market activities.

Regulatory Intelligence & Risk Assessment: Monitor and analyze changes in global regulatory requirements for IVD products. Identify potential risks associated with regulatory non-compliance and propose corrective actions to mitigate these risks.

Audit & Inspection Support: Assist in preparing for and supporting regulatory audits and inspections by FDA and other regulatory agencies. Ensure all documentation, processes, and systems are ready for audit at any given time.

Labeling & Packaging Compliance: Oversee the regulatory review and approval of labeling and packaging for IVD products, ensuring that all labeling complies with regulatory requirements and accurately reflects product claims.

Training & Development: Provide regulatory compliance training to relevant internal teams to ensure adherence to industry standards. Promote a culture of compliance throughout the organization.

Regulatory Reporting & Communication: Maintain clear and concise regulatory records and documentation. Regularly communicate with regulatory agencies, internal stakeholders, and external partners to ensure transparency and alignment with regulatory requirements.

Post-Market Surveillance: Support post-market surveillance activities, ensuring that any regulatory changes or safety issues are promptly addressed and communicated to the appropriate stakeholders.

What the Client is Looking for in You

As the IVD Regulatory Compliance Analyst, the client is seeking an expert in regulatory compliance who brings a solid understanding of the In Vitro Diagnostic (IVD) landscape and the ability to navigate complex global regulatory environments. You should be a detail-oriented professional with experience in managing compliance for IVD products, ensuring quality and safety while maintaining regulatory integrity.

Proven Expertise in IVD Regulatory Compliance

The ideal candidate will have a strong background in regulatory affairs, particularly in the IVD sector. You should have experience working with FDA, ISO, and other global regulatory standards for medical devices. Your ability to interpret and apply complex regulations to ensure product compliance and safety will be key in this role.

Strong Analytical and Problem-Solving Skills

You must possess a keen eye for detail and have the analytical skills to identify and resolve compliance issues. The client is looking for someone who can assess risks, analyze regulatory requirements, and develop solutions to ensure product and process compliance across all stages of the product lifecycle.

Experience in Regulatory Submissions and Documentation

The client is looking for someone with extensive experience in preparing regulatory submissions for IVD products. Your ability to ensure timely and accurate submissions, as well as maintain robust documentation for audits and inspections, will be crucial in supporting regulatory approval and ongoing compliance.

Collaborative and Cross-Functional Team Player

As a key member of the regulatory affairs team, you will need to work closely with R&D, quality assurance, manufacturing, and other departments. The client values candidates who can communicate effectively and collaborate cross-functionally to ensure that all regulatory requirements are integrated into product development and manufacturing processes.

Commitment to Continuous Learning and Regulatory Updates

The regulatory environment is ever-evolving, and the client seeks a candidate who is committed to continuous learning. You should stay up to date with the latest regulatory changes and industry best practices to ensure the company remains compliant with current and future regulations.

Strong Organizational and Project Management Skills

The client is looking for someone who can manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment. Your ability to organize complex regulatory processes and navigate tight timelines will be critical in driving compliance and product success.

Ability to Support Post-Market Surveillance and Risk Management

The ideal candidate will also have experience supporting post-market surveillance and ensuring that any regulatory updates or safety concerns are promptly addressed. The ability to manage risk and implement effective strategies for ongoing compliance after product launch is essential.

Commitment to Quality and Safety

Finally, the client values a professional who has a strong commitment to quality and patient safety. Your role will be critical in ensuring that all IVD products meet the highest standards, providing confidence to customers and regulatory bodies alike.

FAQs About the Role – IVD Regulatory Compliance Analyst – Philadelphia, PA

What are the key responsibilities of the IVD Regulatory Compliance Analyst in this role?

As the IVD Regulatory Compliance Analyst, you will be responsible for ensuring that In Vitro Diagnostic (IVD) products comply with FDA, ISO, and international regulations. Your duties will include managing regulatory submissions, preparing and maintaining documentation, collaborating with cross-functional teams to integrate regulatory requirements, and supporting post-market surveillance. You will also assist in audits and inspections, monitor changes in regulatory requirements, and provide guidance to ensure compliance throughout the product lifecycle.

What qualifications and experience are required for this position?

The ideal candidate should have a solid background in regulatory affairs, with experience in the IVD industry. Familiarity with FDA, ISO, and other international regulatory standards for medical devices is essential. The client is seeking candidates with a proven track record of managing regulatory processes, preparing submissions, and working cross-functionally with other departments. A degree in a relevant field, such as Life Sciences, Regulatory Affairs, or Engineering, is typically required. A certification such as RAC (Regulatory Affairs Certification) is also highly preferred.

What specific skills are important for success in this role?

Success in this role requires strong attention to detail, exceptional analytical skills, and the ability to interpret complex regulations. You should have excellent communication and documentation skills to create accurate regulatory submissions and collaborate effectively with teams. Project management skills are important to handle multiple regulatory tasks and deadlines. Familiarity with post-market surveillance and risk management processes will also be critical.

What challenges can I expect in this role?

As an IVD Regulatory Compliance Analyst, you will face challenges related to the constantly evolving regulatory landscape. Staying up to date with changes in global regulations and ensuring compliance for each product will require ongoing attention to detail and adaptability. Additionally, you may encounter tight timelines for regulatory submissions, especially when navigating complex product approvals. Balancing regulatory requirements with product innovation and development can also be a key challenge.

What is the expected impact of the IVD Regulatory Compliance Analyst on the company’s operations?

The IVD Regulatory Compliance Analyst plays a crucial role in ensuring the company’s IVD products are market-ready and compliant with all necessary regulations. By managing regulatory submissions, supporting audits, and ensuring ongoing compliance, you will directly impact the company’s ability to maintain product quality, minimize regulatory risk, and meet deadlines for market approval. Your work will support the company’s success in the healthcare and diagnostics industry.

What is the company’s culture and work environment like?

The company fosters a collaborative and detail-oriented work culture. They value professionals who are proactive, methodical, and committed to maintaining high standards of compliance and quality. As a member of the regulatory affairs team, you will be part of a dynamic, fast-paced environment where precision and compliance are prioritized. The company encourages continuous learning and provides opportunities for professional growth in the regulatory field.

What Remuneration Can You Expect from This Job?

As the IVD Regulatory Compliance Analyst in Philadelphia, PA, you can expect a competitive compensation package that aligns with industry standards and your level of experience. The remuneration for this role typically includes:

Base Salary

The base salary for an IVD Regulatory Compliance Analyst can vary depending on the company size, complexity of the product portfolio, and geographic location. In Philadelphia, PA, the typical base salary for this role ranges from $70,000 to $120,000 per year. Candidates with specialized experience in the IVD industry may command salaries at the higher end of this range.

Performance-Based Bonuses

Many regulatory roles come with annual performance-based bonuses that are linked to individual and company-wide goals, such as successful regulatory approvals, compliance milestones, and meeting project deadlines. These bonuses can range from 5% to 20% of the base salary, depending on performance and company success.

Equity & Stock Options

Some companies may offer stock options or equity grants to align employee compensation with company success and provide long-term financial incentives. These incentives vary based on the company’s structure and growth stage and could represent a valuable component of your total compensation.

Health & Wellness Benefits

As part of the benefits package, IVD Regulatory Compliance Analysts are typically offered comprehensive health, dental, and vision insurance. Additionally, wellness programs, employee assistance programs, and access to on-site health services may be included.

Retirement Plans & Financial Security

Companies often provide 401(k) plans or pension schemes with company contributions, helping you build long-term financial security. Some companies may offer additional financial planning services or contributions toward retirement savings.

Signing Bonuses & Relocation Assistance

For candidates with specialized experience or those relocating from another region, signing bonuses or relocation assistance may be offered. This can range from $5,000 to $15,000, depending on the candidate’s experience and the company’s policies.

Total Compensation Potential

When factoring in the base salary, bonuses, stock options, and benefits, total compensation for an IVD Regulatory Compliance Analyst in Philadelphia can range from $80,000 to $140,000 annually. Candidates with extensive regulatory experience and a strong track record in the IVD field may see compensation packages at the higher end of this range or above.

How to Apply

If you are an experienced and detail-oriented IVD Regulatory Compliance Analyst with a passion for ensuring compliance in the medical device industry, we invite you to apply for the IVD Regulatory Compliance Analyst role in Philadelphia, PA. This is an exciting opportunity to contribute to a leading company in the in-vitro diagnostic (IVD) field while helping ensure regulatory compliance across multiple markets.

To apply, please submit your updated resume along with a cover letter highlighting your experience in regulatory compliance, knowledge of IVD regulations (e.g., FDA, CE marking), and any relevant certifications. Be sure to demonstrate your expertise in preparing regulatory submissions, managing compliance documentation, and navigating complex regulatory frameworks.

This role offers a significant opportunity to influence the regulatory strategy and ensure that the company’s products meet all necessary compliance standards. Apply today to take the next step in your regulatory career as an IVD Regulatory Compliance Analyst in Philadelphia, PA!

For more information or to explore similar opportunities, visit our Regulatory Compliance Careers Page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Philadelphia

IVD Regulatory Compliance Analyst – Philadelphia, PA