Regulatory Affairs Specialist – Wearable Tech – Pittsburgh, PA

Are you passionate about wearable technology and regulatory compliance? We are looking for a Regulatory Affairs Specialist to join a leading wearable tech company in Pittsburgh, PA. This position offers the opportunity to shape and oversee regulatory strategies for cutting-edge wearable devices in a dynamic and rapidly evolving market. If you have experience in regulatory affairs and a keen interest in wearable technology, this could be your next exciting career move.

Drive Compliance in the Wearable Tech Industry

A leading wearable tech company in Pittsburgh is seeking a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with global standards. The ideal candidate will bring expertise in navigating the regulatory landscape, with a focus on ensuring that products meet the highest quality and safety standards. If you’re ready to make a significant impact in a fast-growing industry and help shape the future of wearable technology, apply today.

Key Responsibilities of the Regulatory Affairs Specialist – Wearable Tech

Regulatory Compliance Management: Ensure that all wearable tech products meet regulatory requirements across global markets. Oversee the preparation and submission of regulatory filings, including FDA approvals, CE marking, and other relevant certifications.

Product Safety & Quality Assurance: Monitor and assess the safety, effectiveness, and quality of wearable tech products to ensure they comply with applicable industry standards and regulations. Collaborate with R&D and product teams to integrate regulatory considerations into the product development lifecycle.

Regulatory Strategy Development: Develop and execute regulatory strategies for new and existing wearable products. Stay up-to-date with regulatory changes and ensure timely and accurate compliance with evolving laws and industry guidelines.

Cross-Functional Collaboration: Work closely with internal teams, including product development, quality assurance, and legal, to provide regulatory guidance throughout the product lifecycle. Ensure regulatory requirements are integrated seamlessly into product design, manufacturing, and marketing processes.

Risk Management & Mitigation: Identify potential regulatory risks and develop mitigation strategies to avoid delays in product launches or market access. Ensure compliance with all regulatory bodies and maintain high standards of risk management.

Documentation & Reporting: Maintain accurate records of regulatory submissions, approvals, and communications with regulatory agencies. Prepare reports and submissions in a timely manner and ensure compliance with documentation requirements.

Regulatory Affairs Education & Training: Provide ongoing education and training to internal teams on regulatory requirements and best practices. Promote awareness of compliance standards across the organization.

Market Surveillance & Post-Market Compliance: Oversee the monitoring of products after they enter the market to ensure continued regulatory compliance. Handle post-market surveillance and manage any adverse event reports or regulatory issues that arise after product release.

Stakeholder Communication: Act as the primary point of contact for regulatory authorities and ensure effective communication regarding product approvals, submissions, and regulatory inquiries. Maintain strong relationships with external regulatory bodies and consultants.

Continuous Improvement: Implement continuous improvement processes within regulatory affairs practices to enhance efficiency and accuracy in compliance activities. Drive innovation in regulatory strategies to ensure competitive market positioning.

What the Client is Looking for in You

As the Regulatory Affairs Specialist – Wearable Tech, the client is seeking an expert who can navigate the complex regulatory environment in the wearable tech industry. You should possess strong attention to detail, a deep understanding of global regulations, and the ability to collaborate across teams to ensure compliance and product safety. The ideal candidate will be passionate about wearable technology and committed to ensuring that all products meet the highest standards of quality and safety.

Proven Expertise in Regulatory Affairs

The client is looking for someone with a solid background in regulatory affairs, particularly in the tech or medical device sectors. You should have experience managing regulatory submissions, certifications, and compliance across various markets. Knowledge of FDA, CE, and other global regulatory frameworks is essential to succeed in this role.

Detail-Oriented with a Focus on Compliance

As a Regulatory Affairs Specialist, you must be detail-oriented and have a strong understanding of regulatory standards. The client values professionals who can maintain meticulous records, handle complex submissions, and manage timelines efficiently to meet all regulatory requirements for wearable tech products.

Strong Communication and Collaboration Skills

The ability to communicate complex regulatory requirements clearly and effectively is critical in this role. The client is looking for someone who can work closely with internal teams (product development, quality assurance, and legal) to integrate regulatory requirements throughout the product lifecycle. Building and maintaining strong relationships with regulatory agencies will also be crucial.

Adaptability and Problem-Solving Skills

Wearable technology is a rapidly evolving industry, and the client is seeking someone who can adapt to changing regulatory landscapes and industry trends. The ideal candidate will be proactive in identifying potential compliance challenges and developing solutions to mitigate risks while keeping product timelines on track.

Understanding of Risk Management and Product Safety

A key part of this role is ensuring product safety and managing risk. The client is looking for a professional who can assess potential risks, ensure compliance with safety standards, and help maintain the integrity of the products from development through post-market surveillance.

Commitment to Continuous Learning

Given the fast-paced nature of the wearable tech industry, the client values a Regulatory Affairs Specialist who is committed to staying updated on the latest regulatory changes, trends, and best practices. A passion for continuous learning and professional development is highly regarded.

Global Regulatory Knowledge

Experience in managing global regulatory submissions and certifications is essential. The client seeks someone who can navigate international markets, ensuring that wearable tech products comply with various regulations and standards around the world.

Strong Ethical Standards and Compliance Focus

The client places high importance on integrity and ethical business practices. The ideal candidate will have a strong focus on maintaining compliance with all regulatory and corporate governance policies while mitigating operational and reputational risks.

FAQs About the Role – Regulatory Affairs Specialist – Wearable Tech

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

As the Regulatory Affairs Specialist, you will be responsible for ensuring that all wearable tech products meet regulatory requirements across global markets. This includes preparing and submitting regulatory filings, managing compliance documentation, and collaborating with cross-functional teams. You will also monitor post-market compliance, address regulatory inquiries, and stay up-to-date with industry regulations to ensure product safety and quality throughout the product lifecycle.

What qualifications and experience are required for this position?

The ideal candidate should have a strong background in regulatory affairs, particularly within the tech or medical device industries. You should have experience managing regulatory submissions, certifications (such as FDA or CE), and global compliance standards. A degree in life sciences, engineering, or a related field is preferred, and additional certifications in regulatory affairs (such as RAC) will be a plus. Experience in the wearable tech or medical device sector is highly desirable.

What technical skills are important for this role?

The client seeks candidates with expertise in regulatory documentation, submission processes, and compliance standards. Familiarity with global regulatory frameworks such as FDA, CE, ISO, and other international regulatory bodies is essential. Additionally, proficiency in regulatory software tools, Microsoft Office, and data management systems is required to maintain accurate records and manage compliance workflows efficiently.

What challenges can I expect in this role?

In this role, you will face challenges related to staying up-to-date with ever-changing global regulations, ensuring timely product approvals, and mitigating risks associated with non-compliance. Navigating complex regulatory requirements while supporting the fast-paced development of innovative wearable products can be demanding. You will also need to effectively communicate and collaborate with various internal teams to ensure all regulatory aspects are integrated seamlessly.

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

The Regulatory Affairs Specialist plays a crucial role in ensuring that wearable tech products comply with all necessary regulations and are safely introduced to market. Your efforts will directly impact the company’s ability to launch products on time, avoid costly regulatory setbacks, and maintain a strong reputation for quality and compliance, all of which are vital for the company’s long-term growth and success.

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

The company offers a dynamic, fast-paced, and innovative work environment, with a strong emphasis on collaboration and teamwork. The culture encourages professional growth and continuous learning, allowing you to stay at the forefront of regulatory affairs in the wearable tech industry. You will be part of a diverse and forward-thinking team, contributing to cutting-edge technology and making a meaningful impact in the industry.

What Remuneration Can You Expect from This Job?

As a Regulatory Affairs Specialist – Wearable Tech in Pittsburgh, PA, you can expect a competitive and comprehensive compensation package. The remuneration for this role typically includes:

Base Salary
The base salary for a Regulatory Affairs Specialist in the wearable tech industry varies depending on experience, education, and the company’s market position. In this role, the annual base salary typically ranges from $80,000 to $120,000, with the possibility of higher compensation for candidates with extensive experience and specialized expertise in wearable tech or medical device regulations.
Performance-Based Bonuses
Many wearable tech companies offer performance-based bonuses to their regulatory affairs team members. These bonuses are often tied to personal and team performance metrics such as timely submission approvals, product compliance achievements, and overall project success. Bonuses can range from 10% to 25% of the base salary, depending on the company’s specific bonus structure and performance goals.
Equity & Stock Options
For certain companies, particularly high-growth startups or larger firms, equity-based compensation may be offered. This could include stock options, restricted stock units (RSUs), or performance shares, aligning your compensation with the company’s long-term success. Equity grants can be a valuable addition to your overall remuneration, potentially leading to significant financial rewards as the company grows.
Profit-Sharing & Long-Term Incentive Plans (LTIPs)
In some cases, profit-sharing or LTIPs may be included in the compensation package. These incentives reward employees for sustained company performance over the years, aligning long-term goals with individual rewards. This type of incentive is designed to ensure that regulatory affairs teams contribute to the company’s long-term success.
Executive Benefits & Perks
As a Regulatory Affairs Specialist, you will likely receive a range of benefits, including:

Health, dental, and vision insurance
401(k) or similar retirement plans with company contributions
Paid time off (PTO) and holidays
Professional development programs or certifications
Company-provided technology and tools for work efficiency

Signing Bonuses & Relocation Assistance
For highly qualified candidates, signing bonuses or relocation assistance may be offered to ease the transition to the company and the Pittsburgh area. These one-time incentives can range from $5,000 to $15,000, depending on the company’s policies and the candidate’s experience.

Total Compensation Potential

When factoring in base salary, bonuses, equity, benefits, and additional perks, total compensation for a Regulatory Affairs Specialist can range from $90,000 to $150,000 annually, with the possibility for higher earnings depending on the company, your qualifications, and overall performance.

How to Apply

If you are an experienced and highly skilled Regulatory Affairs Specialist with expertise in wearable tech, we invite you to apply for the Regulatory Affairs Specialist – Wearable Tech role in Pittsburgh, PA. This is an exciting opportunity to join a leading company in the wearable tech industry and contribute to ensuring regulatory compliance, product approvals, and market readiness.

To apply, please submit your resume and a cover letter outlining your experience in regulatory affairs within the wearable tech or related industries. In your cover letter, highlight your knowledge of regulatory processes, product compliance, risk management, and your ability to drive product approvals in a fast-paced, innovative environment. Emphasize any experience with regulatory submissions, FDA processes, or international regulatory requirements.

This role offers the opportunity to work at the forefront of wearable tech innovation, where you will directly impact the company’s growth and product success. Apply today to take the next step in your career as a Regulatory Affairs Specialist – Wearable Tech in Pittsburgh, PA!

For more information or to explore similar opportunities, visit our Wearable Tech Careers page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Pittsburgh

Regulatory Affairs Specialist – Wearable Tech – Pittsburgh, PA