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Regulatory Affairs Project Manager Jobs (NOW HIRING)

Dentsply Sirona

Regulatory Affairs Manager

Strong leadership, project management, and organizational skills including attention to detail ... Knowledge of regulatory affairs principles and practices. * Ability to critically review detailed ...

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity

$120 - $180/hr

Job Summary: The RA manager leads a team to provide independent regulatory guidance to product ... Plans schedules for regulatory deliverables on a project and monitors project through completion.

New

Dentsply Sirona, Inc

Regulatory Affairs Manager

Strong leadership, project management, and organizational skills including attention to detail ... Knowledge of regulatory affairs principles and practices. * Ability to critically review detailed ...

WilsonCTS

Project Manager - 587-1

Arlington, TN

$81/hr

Coordinate and lead cross-functional teams including Quality, Regulatory Affairs, Manufacturing ... Manage project documentation, change controls, and project governance processes. * Drive ...

Regulatory

Manager, Regulatory Affairs

Sunrise, FL

Maintain documentation and a historical record for projects and provide management with updated ... Makes a proactive contribution to the overall Regulatory affairs department growth. * Provides ...

Wilson Co.

Project Manager - 587-1

Arlington, TX · On-site

$81/hr

Coordinate and lead cross-functional teams including Quality, Regulatory Affairs, Manufacturing ... Manage project documentation, change controls, and project governance processes. * Drive ...

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Regulatory Affairs Project Manager information

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How much do regulatory affairs project manager jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for regulatory affairs project manager in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a regulatory affairs project manager, and why are they important?

To thrive as a Regulatory Affairs Project Manager, you need a solid understanding of regulatory guidelines, project management principles, and a relevant science or engineering degree. Familiarity with regulatory submission systems (such as eCTD), project management tools (like MS Project), and certifications such as RAC are highly valued. Exceptional organizational, communication, and problem-solving abilities set top performers apart in this field. These skills ensure timely regulatory approvals, compliance with global standards, and effective coordination across cross-functional teams.

How does a regulatory affairs project manager typically collaborate with cross-functional teams during product development?

As a Regulatory Affairs Project Manager, you will regularly work with cross-functional teams such as R&D, quality assurance, clinical, and marketing to ensure that projects meet regulatory requirements at every stage. Your role involves coordinating timelines, communicating regulatory expectations, and integrating feedback to guide product development toward successful submissions. Effective collaboration is key, as you'll often lead meetings, resolve regulatory challenges, and provide expert advice to align the team's efforts with evolving global regulations.

What is a regulatory affairs project manager?

A Regulatory Affairs Project Manager is a professional who oversees and coordinates regulatory processes related to product development, approval, and compliance within industries such as pharmaceuticals, biotechnology, or medical devices. They ensure that products meet all required regulatory standards and are submitted to governmental agencies for approval on time. Their role involves managing timelines, collaborating with cross-functional teams, and staying up-to-date with changing regulations to minimize risks and facilitate product launches.

What is the difference between Regulatory Affairs Project Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Project ManagerRegulatory Affairs Specialist
ResponsibilitiesOversees regulatory projects, manages teams, ensures compliance timelinesPrepares documentation, conducts research, supports regulatory submissions
Required CredentialsBachelor's degree, often with project management or regulatory certificationsBachelor's degree, regulatory affairs certifications beneficial
Work EnvironmentCross-functional teams, project-based settings, corporate officesRegulatory departments, laboratories, or manufacturing sites
Industry UsageCommon in pharmaceutical, biotech, medical device companiesWidely used in similar industries for compliance support

The Regulatory Affairs Project Manager focuses on leading regulatory projects, coordinating teams, and ensuring compliance deadlines are met. In contrast, the Regulatory Affairs Specialist handles detailed documentation, research, and supports submissions. Both roles require regulatory knowledge and certifications, but the Project Manager has a broader oversight role, often managing multiple projects simultaneously.

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Regulatory Affairs Project Manager jobs near you
Infographic showing various Regulatory Affairs Project Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Regulatory Affairs Manager

Dentsply Sirona

Remote

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Dentsply Sirona rating

6.3

Company rating: 6.3 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

Requistion ID: 83800
Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands.
Dentsply Sirona's products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona's headquarter is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
This position can be a remote working arrangement. Candidates must be located in the US, ideally in the eastern time zone.
Job Summary:
The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements.
This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Key Responsibilities:
  • Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.
  • Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking.
  • Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions.
  • Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.
  • Coordinates regulatory activities with internal teams and external regulatory agencies.
  • Reviews and approves product labelling and claims for the US and EU markets.
  • Stays current with regulatory requirements and updates affected policies and procedures.
  • Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.
  • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
  • Complies with company and departmental policies and administrative requirements.
  • Performs other duties as assigned or as needed.

Education:
  • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
  • Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master's degree in a scientific discipline is a plus.

Years and Type of Experience:
  • 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
  • Experience with leading regulatory submissions and managing regulatory projects.
  • In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
  • Experience with software as a medical device, AI and/or medical devices containing software is a plus

Required Computer / Software Skills:
  • Proficiency with Microsoft Office Suite
  • Proficiency with Regulatory software

Key Required Skills, Knowledge, and Capabilities:
  • Strong leadership, project management, and organizational skills including attention to detail.
  • Strong written and verbal communication skills.
  • Prior technical writing experience and proven track record with FDA and EU regulatory submissions.
  • Excellent interpersonal skills.
  • Ability to work effectively in a team environment and independently.
  • Knowledge of regulatory affairs principles and practices.
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.
  • Willingness to learn and adapt to new processes and technologies.
  • Leadership experience within medical device organizations.

Key Leadership Behaviors:
  • Actively articulates and promotes Dentsply Sirona's vision and direction.
  • Advocates on behalf of the customer.
  • Values driven with an insistence on excellence.
  • Promotes high performance, innovation, and continual improvement.
  • Consistently meets Company standards, ethics, and compliance requirements.
  • Strong results orientation and analytical skills.
  • Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.
  • Resolves conflicts and fosters a positive working environment.

The base salary and target annual incentive for this remote role is between $154,000 - $165,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law.
Eligibility: All successful applicants must be eligible to work in the country the position is based.
Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona.com.
Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.
Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com.

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