Regulatory Affairs Manager – Regenerative Devices – Cambridge, MA

Are you an experienced regulatory affairs professional with a passion for advancing regenerative medical technologies? We are seeking a Regulatory Affairs Manager to join a leading company in the field of regenerative devices, based in Cambridge, MA. This role offers an exciting opportunity to shape the regulatory strategy and ensure compliance for cutting-edge medical devices that are changing the landscape of healthcare. If you have expertise in regulatory processes and thrive in a fast-evolving industry, this role is for you.

Lead Regulatory Excellence for Groundbreaking Regenerative Devices

A leading company specializing in regenerative medical devices is looking for a Regulatory Affairs Manager to drive regulatory strategies and ensure compliance with FDA, EU, and international regulations. The ideal candidate will have experience navigating complex regulatory environments and working cross-functionally with R&D, quality, and legal teams to bring innovative devices to market. If you are ready to take on a key role in shaping the future of regenerative medicine, apply today!

Key Responsibilities of the Regulatory Affairs Manager – Regenerative Devices

Regulatory Strategy Development: Lead the development and execution of regulatory strategies for regenerative devices, ensuring compliance with FDA, EU, and other international regulations. Work closely with cross-functional teams to create and implement plans for successful product approvals and market access.

Regulatory Submissions & Approvals: Manage the preparation, submission, and follow-up of regulatory filings, including 510(k) premarket notifications, PMAs, and CE marking submissions. Ensure timely approvals and responses to regulatory bodies to facilitate product launch timelines.

Cross-functional Collaboration: Partner with Research & Development, Quality Assurance, and Clinical teams to ensure regulatory requirements are integrated into product development processes. Provide guidance on regulatory impact and ensure that all teams are aligned on regulatory expectations.

Regulatory Compliance Monitoring: Stay updated on evolving regulatory standards, industry trends, and changes to ensure ongoing product compliance. Conduct internal audits and lead efforts to maintain ISO and FDA certifications.

Risk Management & Issue Resolution: Identify regulatory risks and proactively address challenges throughout the product lifecycle. Serve as the primary point of contact for regulatory inquiries and resolve any issues or concerns raised by regulatory agencies.

Regulatory Reporting & Documentation: Ensure the maintenance of accurate regulatory files, documentation, and reports to ensure compliance. Prepare detailed regulatory submissions, responses, and updates for internal teams and external stakeholders.

Global Regulatory Coordination: Coordinate global regulatory activities, including preparation of international submissions and ensuring compliance with different regulatory frameworks for markets such as the EU, Canada, and other global regions.

Regulatory Training & Education: Provide regulatory training and support to internal teams to foster a culture of regulatory awareness. Ensure teams are knowledgeable about relevant regulations and guidelines affecting product development and marketing.

Post-Market Surveillance & Vigilance: Oversee post-market surveillance activities, including adverse event reporting and ongoing monitoring of regulatory requirements. Ensure that post-market data is assessed and reported to regulatory authorities as required.

Regulatory Risk Mitigation: Proactively manage and mitigate regulatory risks through strategic planning and early identification of potential regulatory barriers. Work with senior management to ensure risk management strategies are in place for all regulatory matters.

What the Client is Looking for in You

As the Regulatory Affairs Manager – Regenerative Devices, the client is seeking a highly skilled and detail-oriented professional with extensive experience in regulatory affairs, particularly in the medical device or regenerative medicine sectors. You should possess a deep understanding of FDA and international regulations and have a proven track record of successfully managing regulatory submissions and approvals. The ideal candidate will be a strategic thinker with a proactive approach to compliance, ensuring that products meet all regulatory requirements for safety and efficacy.

Proven Expertise in Regulatory Affairs

The client is looking for a candidate with substantial experience in regulatory affairs within the medical device industry, particularly in regenerative devices. You should have a solid understanding of the regulatory pathways for product approvals, including 510(k), PMA, CE Marking, and other global regulatory frameworks. The ability to navigate complex regulatory environments, develop strategies, and manage the entire regulatory process is essential for this role.

Strategic Thinker with Compliance Focus

The ideal candidate will have the ability to develop and implement effective regulatory strategies that align with the company’s goals and ensure timely product approvals. You should be able to anticipate regulatory challenges and provide solutions to mitigate risks, enabling smooth product development and market entry. Your strategic vision will help ensure that the company remains at the forefront of innovation while complying with all applicable regulations.

Strong Attention to Detail and Analytical Skills

Attention to detail is critical in regulatory affairs, and the client seeks a professional who can meticulously prepare regulatory submissions, analyze complex regulatory data, and identify potential compliance issues before they arise. You should have a strong ability to review and interpret regulations, product documentation, and clinical data to ensure full compliance with all regulatory standards.

Ability to Collaborate Cross-Functionally

The client values a team-oriented individual who can work closely with R&D, quality assurance, legal, and clinical teams to ensure that all regulatory requirements are integrated into the product development process. Your collaborative approach will be essential in driving product approvals while ensuring all teams are aligned on regulatory expectations and objectives.

In-Depth Knowledge of Global Regulatory Standards

A key requirement is familiarity with regulatory requirements and submission processes in multiple regions, including the U.S. (FDA), Europe (CE Marking), and other international markets. You should be able to coordinate global regulatory activities and ensure products meet the standards of various regulatory bodies.

Excellent Communication and Documentation Skills

Clear and concise communication is essential, both in regulatory submissions and in interactions with internal teams and external stakeholders. You should be skilled in preparing comprehensive regulatory reports, submissions, and documentation. The ability to effectively communicate complex regulatory issues and solutions to various stakeholders will be crucial to your success.

Commitment to Quality and Compliance

The client is looking for a candidate who is committed to maintaining the highest standards of quality and compliance in all regulatory activities. You should have a strong understanding of industry standards, quality management systems, and post-market surveillance requirements, ensuring that products meet regulatory standards throughout their lifecycle.

Proactive Problem Solver and Risk Manager

The client seeks a Regulatory Affairs Manager who can identify potential regulatory risks early in the development process and develop strategies to mitigate them. Your ability to proactively address challenges, think critically, and provide solutions will be essential to maintaining compliance and advancing product development timelines.

FAQs About the Role – Regulatory Affairs Manager – Regenerative Devices

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

As the Regulatory Affairs Manager for regenerative devices, you will be responsible for developing and executing regulatory strategies to ensure compliance with FDA, EU, and international regulations. Your duties will include preparing regulatory submissions, managing approvals, working cross-functionally with product development and quality teams, and overseeing post-market surveillance. You will also monitor global regulatory changes, guide teams on compliance matters, and ensure that regulatory documentation is accurate and up-to-date.

What qualifications and experience are required for this position?

The ideal candidate should have a strong background in regulatory affairs, with specific experience in medical devices or regenerative medicine. A degree in a scientific or technical field (such as biology, engineering, or life sciences) is essential, and certification in regulatory affairs (e.g., RAC) is preferred. At least 5-7 years of experience in regulatory affairs, particularly with FDA submissions (e.g., 510(k), PMA) and CE marking, is required. Experience with global regulatory frameworks and post-market surveillance is also beneficial.

What regulatory experience is essential for this role?

You should have hands-on experience with regulatory submissions, including 510(k), PMA, and CE marking, and be well-versed in the regulatory requirements for both U.S. and international markets. Familiarity with FDA regulations, EU Medical Device Regulations (MDR), and international standards such as ISO 13485 is crucial. Additionally, experience with risk management, clinical trials, and post-market surveillance processes will be highly valuable.

What challenges can I expect in this role?

In this role, you will encounter challenges such as navigating complex regulatory pathways, ensuring compliance across different regions, and addressing potential regulatory risks early in the development process. You will need to stay up to date with evolving regulations and adapt strategies to meet changing requirements. Additionally, managing cross-functional teams to align on regulatory expectations while meeting tight product development timelines can be demanding.

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

The Regulatory Affairs Manager plays a critical role in ensuring that regenerative devices meet regulatory standards, allowing the company to bring innovative products to market. Your expertise will help minimize regulatory risks, ensure smooth product approvals, and contribute to the company’s ability to expand its product portfolio globally. By facilitating timely approvals, you will directly impact the company’s market access and long-term growth.

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

The company is committed to innovation, collaboration, and excellence. You will be working in a dynamic, fast-paced environment where teamwork and cross-functional collaboration are key to success. The company values professionals who are proactive, adaptable, and passionate about making a positive impact in the medical device industry. You will be part of a supportive and inclusive team dedicated to improving healthcare outcomes through regenerative medicine.

What Remuneration Can You Expect from This Job?

As the Regulatory Affairs Manager – Regenerative Devices in Cambridge, MA, you can expect a competitive compensation package that reflects your expertise in regulatory affairs and the innovative nature of the medical device industry. The remuneration for this role typically includes:

1. Base Salary
The base salary for a Regulatory Affairs Manager in the regenerative devices sector typically ranges between $100,000 to $150,000 annually, depending on the level of experience, the company’s size, and the complexity of the products being managed. This salary can be adjusted based on your qualifications, including regulatory certifications and industry-specific experience.

2. Performance-Based Bonuses
In addition to a base salary, the compensation package often includes performance-based bonuses. These bonuses are typically tied to key regulatory milestones, such as successful product approvals, market access, and compliance achievement. Annual bonuses can range from 10% to 25% of the base salary, based on individual and company performance.

3. Stock Options & Equity Incentives
Many companies in the medical device sector offer stock options or equity incentives to align the employee’s interests with the company’s long-term success. As a Regulatory Affairs Manager, you may be eligible for stock options or performance shares that provide long-term financial rewards, particularly as the company grows and its products gain market approval.

4. Profit-Sharing & Long-Term Incentives (LTIPs)
Some companies also offer profit-sharing or Long-Term Incentive Plans (LTIPs), which provide additional financial rewards based on the company’s sustained performance and growth. These incentives are typically awarded over multiple years and are designed to ensure that regulatory efforts contribute to the company’s overall success.

5. Executive Benefits & Perks
Regulatory Affairs Managers can expect comprehensive benefits, including:

Health, dental, and vision insurance
401(k) retirement plans with company contributions
Life and disability insurance
Paid time off (PTO) and sick leave
Flexible working hours or remote work options
Professional development opportunities, including regulatory certification programs

6. Signing Bonuses & Relocation Assistance
For highly qualified candidates, some companies offer signing bonuses or relocation assistance to ensure a smooth transition into the role. Signing bonuses may range from $10,000 to $25,000, and relocation packages can cover moving costs, temporary housing, and travel expenses.

Total Compensation Potential

When considering the base salary, performance bonuses, stock options, and additional benefits, the total compensation for a Regulatory Affairs Manager in regenerative devices can range from $120,000 to $200,000+ annually. In high-growth companies or those focused on cutting-edge technologies, compensation packages may exceed this range, offering additional perks and incentives tied to the company’s success.

How to Apply

If you are an experienced regulatory affairs professional with a passion for advancing regenerative medical technologies, we invite you to apply for the Regulatory Affairs Manager – Regenerative Devices role in Cambridge, MA. This is an exciting opportunity to play a key role in ensuring compliance and driving the regulatory strategy for innovative medical devices in the regenerative medicine field.

To apply, please submit your resume and a cover letter outlining your experience in regulatory affairs, particularly in the medical device or regenerative medicine sectors. Highlight your expertise in FDA submissions, CE marking, and global regulatory frameworks. Please also emphasize your ability to navigate complex regulatory environments, your collaboration with cross-functional teams, and your experience in managing product approvals and compliance.

This role offers the chance to make a meaningful impact in a fast-growing sector, working with cutting-edge regenerative devices that are shaping the future of healthcare. Take the next step in your regulatory career and apply today!

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

Job Category: Regenerative Devices

Job Type: Full Time

Job Location: Cambridge

Regulatory Affairs Manager – Regenerative Devices – Cambridge, MA