Regulatory Affairs Manager

Job Description

Job Description

Job Title: Regulatory Affairs Specialist Job Description

This role leads regulatory affairs activities for a defined portfolio of products, ensuring timely regulatory approvals, successful product registrations, and ongoing lifecycle maintenance across multiple global markets. The position coordinates and compiles regulatory documents and submissions, develops and executes global regulatory strategies, and partners closely with internal and external stakeholders to navigate evolving regulatory environments. The Regulatory Affairs Specialist acts as a key contributor and mentor within the regulatory team, driving innovation, continuous improvement, and agile ways of working while safeguarding compliance and enabling worldwide product availability.

• Coordinate, compile, and oversee regulatory documents and submission dossiers for complex products and programs to support timely product registrations in defined markets.
• Develop and manage components of comprehensive global regulatory submissions and registration plans, ensuring alignment with product timelines and market requirements.
• Maintain regulatory approvals and licenses throughout the product lifecycle by applying effective regulatory change control processes and ensuring ongoing compliance.
• Lead and influence regulatory strategies that anticipate and address evolving regulatory requirements, external precedents, and environmental changes across regions.
• Interpret regulatory authority expectations and thinking, and apply this understanding to projects to avoid regulatory obstacles and accelerate global approvals.
• Proactively design and implement innovative regulatory strategies and influencing approaches tailored to the needs of different regions without significant guidance.
• Partner effectively with internal stakeholders and external partners, including authorities, notified bodies, and other organizations, to identify and deliver optimal regulatory solutions.
• Develop and nurture external relationships that influence the current and future direction of products and regulatory strategies, representing the organization in regulatory interactions and audits.
• Contribute to audit preparation and actively participate in audit discussions, providing clear and accurate regulatory information and documentation.
• Understand stakeholder motivations and manage, influence, and negotiate with peers and cross-functional partners to reach mutually beneficial outcomes.
• Foster open exchange of ideas among key stakeholders, encouraging diverse perspectives and facilitating alignment on regulatory and business decisions.
• Make sound, timely decisions, including in areas beyond immediate comfort zone, using good judgment and available information while embracing principles of effective decision making.
• Initiate activities independently, drive cross-functional interactions, and push decision making to the lowest appropriate level, committing to decisions once made.
• Drive innovation across regulatory functions and sites by advocating for new ideas, approaches, and tools that add business value and improve regulatory processes.
• Troubleshoot regulatory issues independently and develop cost-effective, non-complex solutions that ensure daily work is completed without jeopardizing compliance.
• Identify potential regulatory problems before they occur and lead the development and implementation of mitigation strategies to prevent issues.
• Lead others in structured problem-solving activities and continuous improvement initiatives within the regulatory function.
• Act as a role model for leadership behaviors, demonstrating integrity, courage, passion, and reliability while contributing to an inclusive and collaborative environment.
• Serve as a change ambassador by promoting agile mindsets and behaviors, encouraging colleagues to embrace new ways of working and continuous improvement.
• Identify and act on opportunities for process, system, and data improvements within and across quality and regulatory functions.
• Own regulatory data within assigned scope, promote strong data stewardship, and encourage the use of regulatory tools and systems to enhance efficiency and transparency.
• Contribute to or lead projects that leverage understanding of business functions, systems, processes, and data management to support digitalization and strategic goals.
• Mentor and support more junior regulatory employees, actively sharing knowledge, best practices, and experience across the organization.
• Bring people together around common goals, building on diverse perspectives to enhance outcomes and create an atmosphere of openness and trust.
• Address and resolve conflicts constructively, ensuring that team members feel heard and respected while maintaining focus on shared objectives.
• Communicate complex regulatory and strategic concepts clearly and fluently, encouraging direct and open discussions on important issues.
• Provide honest, constructive input even in challenging situations, consistently demonstrating transparency and integrity.
• Recognize and articulate multiple points of view on issues, creating an environment of recognition, appreciation, and active participation.
• Apply daily management and continuous improvement best practices to regulatory processes to enhance efficiency, quality, and consistency.

• 3–5 years of experience in Regulatory Affairs or equivalent with a PhD degree in a relevant field such as IVDs, medical devices, pharmaceuticals, or biopharmaceuticals.
• 5–7 years of experience in Regulatory Affairs or equivalent with a master's degree in a relevant field such as IVDs, medical devices, pharmaceuticals, or biopharmaceuticals.
• 6–8 years of experience in Regulatory Affairs or equivalent with a bachelor’s degree in a relevant field such as IVDs, medical devices, pharmaceuticals, or biopharmaceuticals.
• Significant hands-on experience in regulatory affairs for IVDs, medical devices, pharmaceuticals, or biopharmaceutical products.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• Proven ability to manage high-complexity regulatory work and/or at least parts of global regulatory projects.
• Experience solving complex, critical health authority issues or equivalent high-stakes regulatory challenges.
• Strong understanding of European, US, Chinese, and other international regulatory requirements, with demonstrated ability to interpret and implement quality standards.
• Ability to interpret regulators’ expectations and thinking and apply this understanding to project strategies across different regions.
• Demonstrated ability to develop and execute innovative regulatory strategies that accelerate worldwide approvals.
• Strong stakeholder management and influencing skills, including the ability to build relationships that shape product and regulatory direction.
• Proven decision-making skills, including the ability to make timely decisions with incomplete information while maintaining sound judgment.
• Strong problem-solving skills, including the ability to identify issues early, develop mitigation strategies, and lead others in problem-solving activities.
• Excellent communication skills, with the ability to express complex ideas clearly and fluently and facilitate open, honest discussions.
• Demonstrated ability to lead or significantly contribute to cross-functional initiatives and to bring teams together around common goals.

• Experience working with international regulatory bodies and notified bodies is considered an advantage.
• Experience contributing to or leading audits and regulatory inspections.
• Demonstrated ability to foster an inclusive environment that supports diverse perspectives and backgrounds.
• Experience acting as a mentor or coach for junior regulatory professionals.
• Comfort working in agile and evolving environments, including embracing new technologies and digital tools.
• Entrepreneurial mindset with the ability to identify and seize new opportunities that add business value.
• Experience with regulatory data stewardship and use of regulatory tools and systems to support digitalization and strategic goals.
• Strong interpersonal skills, including conflict resolution, negotiation, and the ability to create win–win outcomes.
• Demonstrated ability to act as a change ambassador, promoting continuous improvement and agile behaviors.

This is an onsite position based on a campus in Indianapolis, Indiana, operating primarily on a first-shift schedule. The role follows a hybrid working model, typically involving two days working remotely and three days onsite each week. The environment emphasizes collaboration across functions, regular interaction with cross-functional teams, and engagement with external stakeholders such as regulatory authorities and notified bodies. The workplace supports the adoption of new technologies, digital tools, and agile practices to simplify processes and increase productivity, with a culture that values continuous improvement, data stewardship, and open communication.

This is a Contract position based out of Indianapolis, IN.

The pay range for this position is $53.00 - $53.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Indianapolis,IN.

This position is anticipated to close on Sep 9, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.