Regulatory Affairs Specialist – Diagnostic Imaging – Philadelphia, PA

Are you passionate about regulatory affairs and have a deep understanding of diagnostic imaging? We are seeking a Regulatory Affairs Specialist to join a leading company in Philadelphia, PA, specializing in diagnostic imaging products. This role presents a unique opportunity to be at the forefront of ensuring that our products meet regulatory requirements while contributing to advancing healthcare technologies. If you have a keen eye for detail and thrive in a dynamic environment, this position is perfect for you.

Shape the Future of Diagnostic Imaging

As a Regulatory Affairs Specialist – Diagnostic Imaging, you will play a pivotal role in ensuring the compliance of innovative diagnostic products with industry regulations. Based in Philadelphia, PA, this role requires a thorough understanding of the regulatory landscape and a proactive approach to meeting the requirements of different health authorities. You will collaborate closely with cross-functional teams, providing guidance and support to ensure product development and market entry are smooth and efficient. If you are an expert in regulatory affairs and passionate about improving healthcare, this is your opportunity to make a significant impact.

Key Responsibilities of the Regulatory Affairs Specialist – Diagnostic Imaging

Regulatory Compliance Management: Ensure that diagnostic imaging products comply with all relevant regulations and standards set by local, regional, and international regulatory bodies. Prepare and submit regulatory filings, approvals, and product registrations to maintain timely product availability in the market.

Regulatory Strategy & Guidance: Develop and execute regulatory strategies for new product launches and existing product maintenance. Provide guidance to cross-functional teams on regulatory requirements, ensuring alignment with development processes, quality systems, and marketing initiatives.

Product Documentation & Reporting: Prepare and review technical files, regulatory submissions, and other required documentation to support product approvals. Ensure accurate and up-to-date records are maintained to demonstrate regulatory compliance.

Cross-Functional Collaboration: Work closely with R&D, quality assurance, manufacturing, and marketing teams to ensure all regulatory requirements are integrated throughout the product lifecycle. Facilitate communication between departments to streamline approval processes and ensure compliance with changing regulations.

Regulatory Intelligence & Risk Management: Monitor and interpret changes in regulatory requirements, industry standards, and guidelines to ensure the company’s products remain compliant. Proactively identify potential regulatory risks and implement mitigation strategies.

Clinical & Technical Expertise: Provide regulatory guidance on clinical trial designs, data analysis, and medical device requirements. Review clinical data and reports to ensure regulatory requirements are met for product approvals and market access.

Submission & Approval Management: Lead the preparation of submissions for regulatory bodies such as the FDA, EMA, and other relevant agencies. Manage the approval process, ensuring that all regulatory requirements are met within established timelines.

Continuous Improvement & Training: Stay updated on industry trends, regulatory updates, and best practices. Conduct training sessions for internal teams to ensure everyone is aligned with regulatory processes and compliance standards.

Stakeholder Engagement: Communicate effectively with regulatory bodies, ensuring smooth interactions and addressing inquiries or concerns regarding product compliance. Build and maintain positive relationships with regulatory authorities to facilitate efficient approval processes.

Quality Assurance & Risk Mitigation: Collaborate with the quality assurance team to ensure that products meet all safety and efficacy standards. Implement risk management processes to minimize regulatory non-compliance and enhance product safety profiles.

What the Client is Looking for in You

As the Regulatory Affairs Specialist – Diagnostic Imaging, the client is seeking an individual with a deep understanding of regulatory compliance, a passion for the diagnostic imaging industry, and the ability to navigate complex regulatory environments. The ideal candidate should possess a combination of technical expertise and strategic thinking to ensure that diagnostic products meet all necessary regulatory standards, enabling their safe and timely market entry.

Proven Regulatory Expertise in Diagnostic Imaging

The client is looking for a seasoned regulatory professional with extensive experience in the diagnostic imaging field. You should have a strong track record of successfully managing regulatory submissions, approvals, and ongoing product compliance. Your expertise in handling complex regulatory requirements, particularly with organizations like the FDA, EMA, and other health authorities, will be crucial in driving success for the company.

Strategic Thinker with a Focus on Compliance

As a Regulatory Affairs Specialist, you will need to craft and execute regulatory strategies that align with the company’s broader business goals. The client seeks someone who can anticipate regulatory changes, navigate evolving industry standards, and maintain compliance across all phases of product development and lifecycle. Your ability to adapt to changing regulations while ensuring that products are delivered on time is critical.

Strong Analytical and Documentation Skills

You must possess excellent attention to detail, ensuring that all regulatory documentation and submissions are completed accurately and on time. The client values individuals who can meticulously review technical files, regulatory submissions, and compliance documentation, ensuring they meet all necessary requirements for product approval.

Ability to Work Cross-Functionally

The client is looking for a Regulatory Affairs Specialist who can work closely with multiple teams, including R&D, manufacturing, and marketing, to ensure that regulatory requirements are integrated throughout the product development process. You should be a strong communicator, able to provide regulatory guidance and foster collaboration among departments to streamline regulatory processes and ensure compliance.

Expertise in Regulatory Intelligence

Staying up to date with regulatory changes and industry trends is essential. The client seeks someone who can actively monitor regulatory updates, assess potential impacts on the business, and provide strategic guidance on risk management and mitigation strategies. Your ability to leverage this knowledge to influence regulatory strategy and minimize compliance risks will be key.

Excellent Communication and Stakeholder Management

The client values professionals who can effectively communicate with regulatory agencies, stakeholders, and internal teams. You should be able to present clear, concise information, respond to regulatory queries, and foster strong relationships with health authorities to ensure smooth regulatory approval processes.

Commitment to Operational Excellence and Product Safety

Finally, the client is looking for a Regulatory Affairs Specialist who is committed to upholding the highest standards of safety and quality in diagnostic imaging products. You should have a strong understanding of the regulatory and quality control processes necessary to bring safe and effective products to market, with a focus on operational efficiency and risk management.

FAQs About the Role – Regulatory Affairs Specialist – Diagnostic Imaging

1. What are the key responsibilities of the Regulatory Affairs Specialist in this role?

As the Regulatory Affairs Specialist – Diagnostic Imaging, you will be responsible for ensuring that all diagnostic imaging products meet regulatory requirements for approval and market entry. Your tasks will include managing regulatory submissions, maintaining compliance throughout the product lifecycle, providing regulatory guidance to cross-functional teams, and ensuring timely approvals from regulatory authorities such as the FDA and EMA. You will also stay updated on regulatory changes, manage risk mitigation strategies, and engage with stakeholders to streamline the regulatory process.

2. What qualifications and experience are required for this position?

The ideal candidate should have a strong background in regulatory affairs, with specific experience in diagnostic imaging or medical devices. You should have a deep understanding of regulatory requirements and submission processes for products in the healthcare industry. A degree in a related field (e.g., life sciences, engineering, or regulatory affairs) is typically required, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Experience working with regulatory bodies like the FDA and EMA, along with a proven track record in handling product approvals, is essential.

3. What skills are essential for success in this role?

Success in this role requires a combination of technical expertise in regulatory affairs and strong interpersonal and communication skills. You should be detail-oriented, with the ability to prepare and review regulatory documentation accurately. Strong problem-solving skills, the ability to adapt to changing regulations, and the capacity to work effectively with cross-functional teams are key. You will also need to stay informed on industry trends and be proactive in managing compliance risks.

4. What challenges can I expect in this role?

In this role, you may face challenges such as navigating complex and ever-changing regulatory requirements, ensuring timely product approvals, and working within tight deadlines. You will need to manage multiple regulatory submissions simultaneously while balancing the demands of cross-functional teams and stakeholders. Regulatory risks, particularly with international market entry, will also require careful attention and proactive mitigation strategies.

5. What is the expected impact of the Regulatory Affairs Specialist on the company’s success?

As the Regulatory Affairs Specialist, your ability to ensure regulatory compliance will have a significant impact on the company’s ability to launch new diagnostic imaging products successfully and within expected timelines. Your work will help mitigate regulatory risks, streamline product approvals, and enable the company to expand its market presence. Your role is critical to the success of product development and the company’s overall growth in the healthcare sector.

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

The company fosters a collaborative and innovation-driven culture, valuing employees who can contribute to regulatory excellence while supporting the development of cutting-edge healthcare products. You will work in a dynamic environment, collaborating with R&D, marketing, and quality teams. The organization values continuous improvement, professional development, and a results-driven approach. It offers a supportive work environment where your expertise will be essential to ensuring product compliance and market success.

What Remuneration Can You Expect from This Job?

As the Regulatory Affairs Specialist – Diagnostic Imaging in Philadelphia, PA, you can expect a competitive compensation package designed to attract highly skilled professionals in the field of regulatory affairs and diagnostic imaging. The remuneration for this role typically includes:

1. Base Salary

The base salary for a Regulatory Affairs Specialist in diagnostic imaging typically ranges from $80,000 to $120,000 annually, depending on your level of experience, qualifications, and the size of the company. Larger organizations or those with a global presence may offer higher base salaries for candidates with extensive experience.

2. Performance-Based Bonuses

In addition to the base salary, many companies offer annual performance-based bonuses. These bonuses are usually tied to key performance indicators (KPIs) such as successful regulatory submissions, timely product approvals, and overall compliance performance. Bonus potential can range from 10% to 25% of the base salary, depending on both individual and company performance.

3. Equity & Stock Options

Some organizations may offer equity-based incentives, such as stock options or restricted stock units (RSUs), especially if the company is publicly traded or is in a growth phase. These incentives align your financial success with the company’s long-term goals and can provide substantial rewards as the company grows and succeeds in the market.

4. Benefits & Perks

Regulatory Affairs Specialists typically receive a comprehensive benefits package, which includes:

Health, dental, and vision insurance
401(k) retirement plan with employer matching contributions
Paid time off (PTO) and sick leave
Life insurance and disability coverage
Wellness programs and mental health support
Professional development and certification reimbursement
Employee assistance programs

5. Signing Bonuses & Relocation Assistance

For candidates with specialized experience or those relocating from another area, companies may offer signing bonuses or relocation assistance packages. These incentives can range from $5,000 to $20,000, depending on the specific needs and negotiation terms.

Total Compensation Potential

When factoring in base salary, performance bonuses, stock options, and benefits, total compensation for a Regulatory Affairs Specialist in diagnostic imaging can range from $90,000 to $160,000 annually. Candidates with significant expertise or working for larger firms may see even higher compensation packages, with additional incentives for long-term performance and company success.

How to Apply

If you are an experienced and highly motivated professional in regulatory affairs with a strong background in diagnostic imaging, we encourage you to apply for the Regulatory Affairs Specialist – Diagnostic Imaging role in Philadelphia, PA. This is an exciting opportunity to contribute to the development and approval of innovative diagnostic products while ensuring regulatory compliance across multiple markets.

To apply, please submit your resume and a cover letter outlining your experience in regulatory affairs, particularly within the diagnostic imaging or medical device sector. In your cover letter, be sure to emphasize your expertise in regulatory submissions, FDA and EMA regulations, risk management, and your ability to work collaboratively with cross-functional teams. Additionally, highlight your familiarity with industry standards and your success in navigating complex regulatory requirements to bring safe and effective products to market.

This role offers the opportunity to make a significant impact on the company’s regulatory strategy and growth while working in a dynamic and collaborative environment. Apply now to advance your career in regulatory affairs and help shape the future of diagnostic imaging!

For more information or to explore similar opportunities, visit our Regulatory Affairs Jobs Page.

Job Category: Diagnostic Imaging

Job Type: Full Time

Job Location: Philadelphia

Regulatory Affairs Specialist – Diagnostic Imaging – Philadelphia, PA