Regulatory Affairs Manager, OAS

Wellspect HealthCare; Sarasota (FL); On-site; USD 154,000 - 165,000; Full time

Job summary

Dentsply Sirona, a global leader in dental products, seeks a Regulatory Affairs Manager to oversee regulatory strategies and submissions for medical devices worldwide, with mentorship of a RA team. You will coordinate with FDA, Health Canada and EU bodies and ensure compliance across Canada, US, and EU markets.

The role combines strategic regulatory leadership with hands-on submissions and cross-functional collaboration in a hybrid work model, with Sarasota, FL as a potential site.

Qualifications

• Bachelor's degree in life sciences or regulatory affairs.
• Regulatory Certification (RAC) or Master’s degree is a plus.
• 5+ years of regulatory affairs experience, preferably in medical devices.
• Experience with FDA 510(k) and international regulations (EN ISO 13485, MDSAP, EU MDR).
• Experience with software as a medical device, AI and/or software-containing devices.

Responsibilities

• Develop regulatory strategies to obtain and maintain approvals globally.
• Lead regulatory submissions including 510(k) and CE/Canada licensing.
• Manage communications with FDA, Health Canada and EU notified bodies.
• Provide regulatory guidance to cross-functional teams throughout product lifecycle.
• Coordinate activities with internal teams and external agencies.
• Review product labeling and claims for multiple markets.
• Mentor and manage day-to-day activities of junior staff.

Skills

Leadership

Project management

Regulatory affairs

Communication

Education

Bachelor's degree in life sciences

Regulatory Certification RAC

Tools

Regulatory software

Microsoft Office

Job description

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history 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 dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

Working at Dentsply Sirona you are able to:

Develop faster - with our commitment to the best professional development.

Perform better - as part of a high-performance, empowering culture.

Shape an industry - with a market leader that continues to drive innovation.

Make a difference -by helping improve oral health worldwide.

Job Summary

The primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Orthodontics RA 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 Canada, EU and US 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, licensing in Canada, and technical files for CE marking.
• Manages communications with FDA, Health Canada and EU notified bodies on behalf of the company for submission related discussions.
• 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 Canada, 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, MDSAP, EU MDR).
• Experience with software as a medical device, AI and/or medical devices containing software.

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 Canada, US 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.
• 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.

This position is a hybrid working arrangement, working 4 days on-site and one remotely. This role can be filled at one of the following Dentsply Sirona locations:

• Calexico, CA
• Charlotte, NC
• Johnson City, TN
• Lancaster, PA
• Sarasota, FL
• York, PA

DentsplySirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in DentsplySirona.

If you need assistance with completing the online application due to a disability, please send an accommodation request to [e-mail] . Please be sure to include "Accommodation Request" in the subject.

We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).

The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).