Regulatory Affairs Specialist (Innovation)

RXinsider LTD.; Northern (KY); Hybrid; USD 96,000 - 153,000; Full time

Job summary

Waters is seeking a Regulatory Affairs Specialist (Innovation) to provide regulatory guidance, develop strategies, and conduct risk assessments for new product development (IVD devices, automated laboratory systems, and software).

This role coordinates FDA submissions (Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k)) and EU IVDR dossiers, partnering with R&D, Quality, Medical Affairs, and Marketing to drive compliant, innovative solutions in a fast-moving healthcare tech environment.

Qualifications

• Experience interpreting regulations and managing complex regulatory requirements.
• Ability to coordinate with R&D, Quality, Medical Affairs, and Program Management.
• Experience with FDA submissions and EU IVDR documentation.

Responsibilities

• Serves as Regulatory Affairs SME on NPD teams.
• Organizes and leads FDA & EU IVDR submissions.
• Collaborates with cross-functional teams to address regulatory risks and ensure compliant development.

Skills

Regulatory Affairs

FDA Submissions

EU IVDR

Cross-functional collaboration

Quality Systems

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We Are The People Who Give Possibilities Purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) devices, automated laboratory systems, and related software products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.

The ideal candidate is an adaptable and solution-oriented professional with experience in regulated healthcare products who is excited by innovation and continuous learning. The ideal candidate enjoys collaborating with scientists, engineers, clinicians, and business leaders to solve complex problems and guide products through development and regulatory approval.

Responsibilities

• Serves as Regulatory Affairs SME on various new product development (NPD) teams
• Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
• Recognizes and addresses potential regulatory risks with project plans
• Responsible for organizing and leading various FDA & EU IVDR submissions
• Serves as contact to FDA and Notified Body review teams during submission reviews/communication
• Recognizes and proposes continuous process improvements.

Required Education And Experience

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline
• 2-5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s) (relevant experience in IVDs, medical devices, laboratory systems, or related regulatory healthcare technologies within a quality or technical position may be considered)

Preferred Skills And Experience

• Demonstrated experience in interpreting subjective and complex aspects of specific regulations
• Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
• Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
• Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions, preferably as primary author
• Experience with IVDs is desirable, but we also welcome candidates from medical device, digital health, software, or other regulated healthcare backgrounds who are eager to apply their expertise to next-generation diagnostic technologies

Skills

• Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.

Technical & Functional

• Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
• Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
• Understanding of regulatory submission processes and lifecycle management

Communication & Collaboration

• Strong written and verbal communication skills
• Experience working with cross-functional, fast-moving teams
• Confidence in speaking up within cross-functional teams when regulatory risks are present

Process & Compliance

• Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
• Ability to identify and support process improvements

Other

• Strong organizational skills and ability to manage multiple submissions/projects simultaneously
• Adaptability to changing timelines and priorities
• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)

We prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with our Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$95,900.00 - $153,400.00 USD Annual