Regulatory Affairs Manager – Surgical Devices – Boston, MA
Are you an experienced regulatory affairs professional with expertise in the medical device industry? We are looking for a Regulatory Affairs Manager to oversee the regulatory compliance and approval processes for cutting-edge surgical devices in Boston, MA. This role offers an exciting opportunity to work with a dynamic team, ensuring the safe and effective delivery of innovative medical solutions to the market. If you have a strong background in regulatory affairs, specifically with surgical devices, and thrive in a fast-paced, results-driven environment, we want to hear from you.
Drive Innovation in Surgical Device Regulation
Our client, a leading company in the surgical device sector, is seeking a Regulatory Affairs Manager to lead regulatory efforts for their growing portfolio of products. The ideal candidate will have in-depth knowledge of FDA and international regulations, a strong understanding of medical device submissions, and a proven track record in driving successful product registrations. If you’re passionate about ensuring regulatory compliance while supporting product innovation, this is the role for you to shape the future of surgical devices.
Key Responsibilities of the Regulatory Affairs Manager – Surgical Devices
Regulatory Strategy & Leadership:
Develop and implement regulatory strategies to support the approval and market launch of surgical devices. Lead regulatory submissions and ensure compliance with FDA, EMA, and other global regulatory bodies. Guide the team on navigating complex regulatory requirements, ensuring alignment with business goals and market demands.
Regulatory Compliance & Documentation:
Oversee the preparation and submission of regulatory documents for product approvals, including 510(k) submissions, PMAs, and CE mark applications. Ensure timely and accurate filing of regulatory documents, maintaining high standards of documentation and ensuring compliance with all relevant regulations.
Cross-functional Collaboration:
Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure regulatory requirements are integrated early in the product development lifecycle. Provide regulatory guidance on design controls, labeling, risk management, and clinical trials to ensure smooth product development and market access.
Risk Management & Regulatory Strategy:
Conduct risk assessments to identify potential regulatory obstacles and propose strategies to mitigate risks. Lead risk management initiatives to ensure compliance with international regulatory standards and to facilitate seamless product approvals in key markets.
Regulatory Intelligence & Market Trends:
Stay up to date with the latest developments in regulatory requirements for surgical devices. Monitor and analyze changes in regulations, industry standards, and guidelines to ensure the company maintains compliance and remains competitive in the global marketplace.
Global Regulatory Compliance:
Manage regulatory submissions across multiple markets and regions, ensuring compliance with local, national, and international regulatory requirements. Coordinate with global teams to drive efficient product approvals and ensure smooth entry into international markets.
Post-market Surveillance:
Lead post-market surveillance activities, ensuring compliance with regulatory requirements for reporting adverse events, complaints, and device recalls. Track and report on product performance, ensuring adherence to post-market regulatory obligations and quality standards.
Continuous Improvement:
Contribute to the development and improvement of internal regulatory processes and procedures. Lead initiatives aimed at improving the efficiency and effectiveness of regulatory operations, ensuring alignment with industry best practices.
Team Development & Mentorship:
Mentor and develop junior regulatory affairs team members, fostering a culture of continuous learning and professional growth. Lead training initiatives to ensure the team is well-versed in regulatory requirements and industry standards.
What the Client is Looking for in You
As the Regulatory Affairs Manager – Surgical Devices, the client is seeking a highly skilled and detail-oriented regulatory affairs expert with a deep understanding of the surgical device industry. You should possess a strong track record of managing regulatory submissions, navigating complex regulatory landscapes, and ensuring compliance with FDA and international standards. The ideal candidate will have the ability to work in a dynamic, fast-paced environment while ensuring the timely approval and market access for innovative surgical devices.
Proven Expertise in Regulatory Affairs
The client is looking for a seasoned professional with extensive experience in regulatory affairs within the medical device industry, particularly in surgical devices. You should have a comprehensive understanding of the FDA submission processes, including 510(k), PMA, and IDE applications, as well as experience with CE marking and international regulatory requirements. A strong ability to oversee and manage the regulatory submission lifecycle and product approvals is essential.
Strong Knowledge of Regulatory Standards & Compliance
As the Regulatory Affairs Manager, you must be well-versed in the regulatory standards governing surgical devices. The ideal candidate will have a proven ability to interpret and apply complex regulations, such as FDA 21 CFR, ISO standards, and clinical trial regulations, ensuring compliance and smooth product approvals. You should be able to keep up with ever-evolving industry regulations and provide strategic guidance on regulatory matters to the cross-functional team.
Strategic Problem-Solver with Attention to Detail
The client seeks a proactive problem-solver who can address regulatory challenges and find solutions to overcome regulatory hurdles. You should have excellent attention to detail and the ability to navigate complex technical documentation and compliance requirements. The ability to anticipate potential regulatory issues and mitigate risks while ensuring timely product approvals is crucial for this role.
Collaborative Team Player
You must be a strong communicator and collaborator, working closely with R&D, Quality Assurance, and Manufacturing teams to ensure that regulatory requirements are met throughout the product development lifecycle. The client values team players who can effectively work across departments, manage cross-functional projects, and provide regulatory input to support the successful development of surgical devices.
Global Regulatory Knowledge
The client is looking for a candidate with experience handling regulatory submissions for multiple global markets, including the US, Europe, and other international regions. You should have a strategic approach to regulatory affairs and a deep understanding of the global regulatory landscape to ensure the company’s surgical devices can be marketed internationally.
Ability to Manage Risk & Compliance
Risk management and compliance are central to this role. The client seeks a candidate who is able to assess potential risks in regulatory pathways and devise strategies to mitigate these risks. You should have a strong understanding of post-market surveillance, including vigilance reporting and managing adverse event reporting, to ensure ongoing regulatory compliance.
Leadership and Development of Regulatory Team
The ideal candidate will have leadership experience and a commitment to developing a high-performing regulatory affairs team. You should be able to mentor and guide team members, ensuring continuous professional development and fostering a collaborative work environment. Leadership skills and the ability to oversee team projects and priorities are essential in this role.
FAQs About the Role – Regulatory Affairs Manager – Surgical Devices
1. What are the key responsibilities of the Regulatory Affairs Manager in this role?
As the Regulatory Affairs Manager, you will be responsible for ensuring the regulatory compliance of surgical devices, managing submissions for FDA approvals, and ensuring timely market access. You will lead regulatory filings, including 510(k), PMA, and CE mark applications, and collaborate with cross-functional teams to integrate regulatory requirements throughout the product development lifecycle. Additionally, you will oversee post-market surveillance and ensure ongoing compliance with industry regulations.
2. What qualifications and experience are required for this position?
The ideal candidate should have a strong background in regulatory affairs within the medical device industry, particularly surgical devices. A deep understanding of FDA regulations (including 21 CFR), international regulatory standards, and submission processes (510(k), PMA, IDE) is essential. The client is looking for candidates with at least 5 years of regulatory affairs experience, with a proven track record of successfully managing regulatory submissions. A degree in a relevant field (e.g., Life Sciences, Engineering) is required, and certifications in regulatory affairs (e.g., RAC) are preferred.
3. What skills and qualities are essential for this role?
The client seeks a detail-oriented, proactive, and strategic thinker who can navigate complex regulatory landscapes with ease. Strong problem-solving skills, excellent communication, and the ability to collaborate with cross-functional teams are crucial. The ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment is also essential. Additionally, the candidate should have a strong understanding of risk management, regulatory compliance, and global market requirements.
4. What challenges can I expect in this role?
As a Regulatory Affairs Manager in the surgical device industry, you will face challenges such as managing complex regulatory submissions across multiple regions, ensuring timely approvals while meeting stringent regulatory requirements. You will need to address regulatory hurdles and adapt to changing regulations, especially in a fast-evolving industry. Maintaining compliance across global markets and managing post-market surveillance will also present ongoing challenges.
5. 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 the company’s surgical devices meet all regulatory requirements, enabling the products to reach the market efficiently. Your success in securing timely approvals and ensuring compliance will directly impact the company’s ability to expand market share, meet customer demand, and maintain product quality and safety standards. You will contribute to the company’s reputation as a leader in the surgical device industry.
6. What is the company’s culture and work environment like?
The company fosters a collaborative, innovative, and compliance-driven culture. They value individuals who are results-oriented, detail-focused, and able to navigate complex regulatory environments. You will have the opportunity to work in a dynamic, fast-paced setting with a team of professionals who are passionate about advancing medical technology. The company encourages continuous learning and provides opportunities for professional development within the regulatory affairs field.
What Remuneration Can You Expect from This Job?
As the Regulatory Affairs Manager – Surgical Devices in Boston, MA, you can expect a highly competitive compensation package designed to attract experienced professionals in the regulatory affairs field. The remuneration for this role typically includes:
1. Base Salary
The base salary for a Regulatory Affairs Manager in the surgical device industry can vary depending on experience, company size, and market conditions. On average, the annual base salary for this role in Boston ranges from $100,000 to $140,000. Highly experienced professionals with specialized skills in surgical devices and regulatory affairs may earn higher salaries.
2. Performance-Based Bonuses
In addition to a base salary, many companies offer performance-based bonuses that reward regulatory milestones, such as successful submissions and timely approvals. These bonuses can range from 10% to 30% of the base salary, depending on individual performance, company performance, and regulatory achievements.
3. Equity & Stock Options
Some companies may offer equity-based compensation, including stock options or restricted stock units (RSUs), which align the interests of regulatory affairs managers with the company’s long-term success. Equity incentives vary by company and can contribute to significant long-term financial rewards.
4. Retirement & Financial Benefits
Many companies offer comprehensive retirement and financial benefits, including:
- 401(k) plans with employer contributions
- Employee stock purchase plans (ESPP)
- Pension plans or other retirement savings options
These benefits help you plan for a secure future and can supplement your compensation package.
5. Health & Wellness Benefits
Regulatory Affairs Managers typically receive health, dental, and vision insurance, with premiums often covered by the employer. Additional wellness programs, mental health support, and executive health services may also be part of the benefits package.
6. Signing Bonuses & Relocation Assistance
For highly qualified candidates, signing bonuses and relocation assistance packages may be offered. These one-time incentives can vary widely but typically range from $5,000 to $20,000 depending on the candidate’s experience, current location, and relocation requirements.
Total Compensation Potential
When factoring in the base salary, performance bonuses, equity incentives, and benefits, total compensation for a Regulatory Affairs Manager in the surgical devices field can range from $120,000 to $200,000 annually. Highly experienced professionals with specialized expertise may command even higher total compensation.
How to Apply
If you are an experienced professional in regulatory affairs with a strong background in the surgical devices sector, we invite you to apply for the Regulatory Affairs Manager – Surgical Devices role in Boston, MA. This is an exciting opportunity to lead regulatory efforts, ensuring the compliance and market access of surgical devices in a fast-paced and innovative industry.
To apply, please submit your updated resume and a cover letter highlighting your experience in regulatory affairs, FDA submissions, CE mark processes, and your familiarity with global regulatory standards. Be sure to emphasize your ability to navigate complex regulations, lead cross-functional teams, and drive successful product approvals in the medical device field.
This role offers a fantastic opportunity to contribute to the success of a cutting-edge surgical device company. Apply today to take the next step in your regulatory affairs career!
For more information or to explore similar opportunities, visit our Medical Device Regulatory Careers page.
Tags: Regulatory Affairs Manager | Surgical Devices | FDA Submissions | Regulatory Affairs Jobs | Medical Device Compliance | CE Mark Approval | 510(k) Process | Regulatory Strategy | Medical Device Industry Careers
