Bioengineering Regulatory Affairs Manager Job Description [Updated for 2025]

In the progressive era of biotechnology, the role of Bioengineering Regulatory Affairs Managers has become increasingly significant.

As advancements in bioengineering continue to accelerate, there is a growing demand for skilled professionals who can navigate, reinforce, and oversee our regulatory landscape within this field.

But what exactly is expected from a Bioengineering Regulatory Affairs Manager?

Whether you are:

• A job seeker trying to understand the intricacies of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the complexities of bioengineering regulatory affairs,

You’ve landed at the right place.

Today, we present a customizable Bioengineering Regulatory Affairs Manager job description template, crafted for easy posting on job boards or career sites.

Let’s delve right into it.

Bioengineering Regulatory Affairs Manager Duties and Responsibilities

Bioengineering Regulatory Affairs Managers apply their bioengineering background and knowledge of regulatory guidelines to ensure that their organization’s products are in compliance with international and domestic regulatory standards.

Their primary duties and responsibilities include:

• Overseeing the development of regulatory strategies and plans for the organization’s bioengineering products
• Coordinating with teams to prepare and submit documentation required by regulatory agencies
• Assessing proposed changes to bioengineered products to determine the need for regulatory submissions
• Keeping abreast of regulatory procedures and changes in regulatory climate to ensure compliance
• Maintaining relationships with regulatory bodies and staying updated on international regulatory requirements
• Interpreting regulatory rules and guiding the organization’s bioengineering product development teams
• Collaborating with clinical and product development teams to ensure regulatory compliance throughout all stages of product development
• Training and supervising regulatory affairs staff to ensure they are knowledgeable about current regulations
• Reviewing promotional materials to ensure all claims made are in compliance with regulations
• Ensuring quality control systems are effective and meet the standards set by regulatory authorities

 

Bioengineering Regulatory Affairs Manager Job Description Template

Job Brief

We are seeking a detail-oriented Bioengineering Regulatory Affairs Manager to oversee our organization’s compliance with health, safety, and environmental regulations related to our bioengineering products.

Your responsibilities will include understanding the regulatory landscape, guiding product development teams in compliance with regulations, and preparing appropriate documentation for regulatory submissions.

Our ideal candidate holds an advanced degree in Bioengineering, Biomedical Engineering, or a related field, and has a strong understanding of regulatory affairs in the healthcare and biotechnology industries.

 

Responsibilities

• Develop and implement regulatory strategies for bioengineering products
• Guide product development teams to ensure compliance with regulations
• Prepare and submit documentation for regulatory submissions
• Interact with regulatory bodies and represent the company during regulatory inspections
• Maintain current knowledge of relevant regulations, including proposed and final rules
• Participate in internal and external audits
• Manage and mentor regulatory affairs staff
• Collaborate with other departments to address potential regulatory issues

 

Qualifications

• Proven work experience in a regulatory affairs management role within the bioengineering or healthcare industry
• Advanced degree in Bioengineering, Biomedical Engineering, or a related field
• Extensive knowledge of local, national, and international regulatory requirements
• Strong leadership, communication, and organizational skills
• Ability to handle multiple projects and meet deadlines
• Proficiency with regulatory submission software tools, publishing tools, and document management systems

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Bioengineering Regulatory Affairs Manager
• Work Environment: Office setting with potential for remote work. Some travel may be required for regulatory inspections and meetings.
• Reporting Structure: Reports to the Director of Regulatory Affairs.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $95,000 minimum to $155,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Bioengineering Regulatory Affairs Manager Do?

Bioengineering Regulatory Affairs Managers typically work in the biotechnology or pharmaceutical industries.

They may also find employment in medical device manufacturing companies, hospitals, or healthcare facilities.

They are responsible for ensuring that their organization’s products comply with all national and international regulatory standards.

This involves developing and implementing regulatory strategies for new products and making sure that the existing products are in line with the evolving regulatory rules.

Their job includes reviewing and approving promotional materials for products to ensure they are compliant with the regulations.

They also participate in the product development process to provide inputs on regulatory requirements.

Bioengineering Regulatory Affairs Managers often work closely with other departments such as research and development, quality assurance, and legal departments.

They review and prepare documentation for submission to regulatory agencies, and follow up on these submissions until approval is received.

They may also be responsible for monitoring regulatory landscape, identifying changes in regulations, and communicating these changes to relevant departments within the organization.

They must have the ability to interpret complex regulatory laws and guidelines and apply them in different scenarios.

In addition to these, they are also involved in internal and external audits, and they ensure that their organization is ready for inspections by regulatory bodies at all times.

They play a key role in managing any risk associated with regulatory non-compliance, and they lead initiatives to improve regulatory compliance within the organization.

 

Bioengineering Regulatory Affairs Manager Qualifications and Skills

Bioengineering Regulatory Affairs Managers utilize a mix of technical knowledge, industry-specific understanding and managerial skills to ensure that products meet necessary standards.

These may include:

• Knowledge of bioengineering principles and technologies to understand the products and processes within the organization.
• Familiarity with regulatory standards and legal requirements within the bioengineering industry and the ability to interpret and apply them to company projects.
• Strong analytical skills to review and evaluate regulatory documentation, ensuring all information is accurate and compliant with industry guidelines.
• Excellent managerial skills to oversee the regulatory affairs team, assign tasks, and monitor performance.
• Effective communication skills to liaise with various departments within the company, as well as external agencies and regulatory bodies.
• Problem-solving skills to address and resolve any compliance issues that may arise during product development or post-market surveillance.
• Attention to detail to ensure all paperwork, reports, and submissions are accurate and complete.
• Ability to stay updated on changing regulations in the bioengineering field and implement necessary changes in the company’s policies or processes.

 

Bioengineering Regulatory Affairs Manager Experience Requirements

Bioengineering Regulatory Affairs Managers typically require at least a bachelor’s degree in Bioengineering, Biomedical Engineering or related field.

However, many employers prefer candidates with a Master’s degree in Regulatory Affairs, Business Administration or a related discipline.

Entry-level candidates may have 2 to 3 years of experience, often gained through internships or roles within regulatory affairs or quality assurance in the bioengineering or biomedical industry.

These professionals can also gain valuable experience in roles such as Regulatory Affairs Associate, Quality Assurance Specialist or Clinical Research Associate.

Candidates with more than 5 years of experience often have developed their technical skills and knowledge in roles such as Regulatory Affairs Specialist, Regulatory Affairs Coordinator or Compliance Officer within the bioengineering sector.

Those with more than 7 years of experience, including 3 years in managerial roles, are typically considered for a Bioengineering Regulatory Affairs Manager position.

This should ideally include experience in leading teams, overseeing regulatory submission processes, and liaising with relevant regulatory bodies in the bioengineering or biomedical field.

In addition, extensive knowledge of international, federal and state regulations pertaining to bioengineering products and processes, such as FDA and EU regulations, is necessary.

They should also be proficient in risk management and have strong communication and strategic planning skills.

Professional certification, such as the Regulatory Affairs Certification (RAC), can further enhance a candidate’s qualifications and are often preferred by employers.

 

Bioengineering Regulatory Affairs Manager Education and Training Requirements

Bioengineering Regulatory Affairs Managers usually hold a bachelor’s degree in bioengineering, biomedical engineering, or a related field.

In addition to their degree, they often possess a deep understanding of biological and medical science, and have training in the application of engineering principles to biological systems.

Regulatory affairs managers must also have a firm grasp of regulatory policies and procedures, often obtained through experience in the field.

Therefore, it is not uncommon for them to have worked previously in roles such as regulatory affairs associates or specialists.

Those seeking to advance their careers further might opt for a master’s degree in regulatory science, bioengineering, or health administration.

Some universities also offer advanced degrees specifically in regulatory affairs, which provide a comprehensive understanding of the global regulatory environment.

As part of their training, they are expected to be familiar with various regulations such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations.

As such, certifications from these regulatory bodies can also prove beneficial.

A bioengineering regulatory affairs manager must not only have technical expertise but also possess strong leadership and communication skills, as the role often requires interaction with various stakeholders and leading diverse teams.

Therefore, any training in leadership, communication, or project management can be advantageous.

Continuing education is also crucial in this field due to the ever-evolving nature of regulatory standards and advancements in bioengineering technologies.

This can be achieved through seminars, workshops, and courses offered by professional organizations or regulatory bodies.

 

Bioengineering Regulatory Affairs Manager Salary Expectations

A Bioengineering Regulatory Affairs Manager can expect to earn an average salary of $121,937 (USD) per year.

The salary could vary depending on factors such as years of experience, specific skills, the company, and the geographical location.

 

Bioengineering Regulatory Affairs Manager Job Description FAQs

What skills does a Bioengineering Regulatory Affairs Manager need?

Bioengineering Regulatory Affairs Managers should have a deep understanding of regulatory guidelines in bioengineering and be able to interpret and implement them in a practical setting.

They need strong project management skills and should be good at multitasking.

Additionally, they should have excellent verbal and written communication skills, as they interact with a variety of stakeholders, including scientists, engineers, and regulatory authorities.

Analytical thinking and attention to detail are also important skills.

 

Do Bioengineering Regulatory Affairs Managers need a degree?

Yes, Bioengineering Regulatory Affairs Managers usually need a degree in bioengineering, biomedical engineering, or a related field.

Some also have a master’s degree or a PhD.

In addition to formal education, they need extensive experience in bioengineering and regulatory affairs.

Some companies also prefer candidates with a certification from a regulatory affairs professional society.

 

What should you look for in a Bioengineering Regulatory Affairs Manager resume?

A Bioengineering Regulatory Affairs Manager’s resume should demonstrate substantial experience in bioengineering and regulatory affairs.

It should outline projects they have overseen and highlight their knowledge of the regulatory landscape.

In addition, it should mention any specialized training or certification in regulatory affairs.

Lastly, it should also showcase their skills in communication, project management, and problem-solving.

 

What qualities make a good Bioengineering Regulatory Affairs Manager?

A good Bioengineering Regulatory Affairs Manager is proactive and able to anticipate potential regulatory issues before they arise.

They are detail-oriented and meticulous in their work, ensuring compliance with all regulations.

They are effective communicators who can facilitate collaboration between different teams and explain complex regulatory requirements to non-specialists.

Lastly, they are committed to continuous learning and stay updated with the latest advancements in bioengineering and regulatory affairs.

 

What are the challenges in hiring a Bioengineering Regulatory Affairs Manager?

Given the niche nature of this role, finding a suitable Bioengineering Regulatory Affairs Manager can be challenging.

The candidate must have a strong background in bioengineering and a deep understanding of regulatory affairs, which is a combination that is not easily found.

Therefore, companies may need to invest significant time and resources in their search for the right candidate.

 

Conclusion

And there we have it.

Today, we’ve unveiled the complex world of being a Bioengineering Regulatory Affairs Manager.

Surprise!

It’s not just about managing regulations.

It’s about molding the future of healthcare, one compliance at a time.

With our comprehensive Bioengineering Regulatory Affairs Manager job description template and real-world examples, you’re ready to take the next step.

But why stop at just understanding?

Delve further with our job description generator. It’s your tool for creating meticulous job listings or refining your resume to perfection.

Remember:

Every compliance measure is a part of the larger healthcare landscape.

Let’s shape that future. Together.

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