Regulatory Affairs Manager

Requistion ID: 83800 reputed company 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. reputed company 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. reputed company’s products reputed company innovative, high-quality, and effective solutions to advance patient care and deliver reputed company and safer dental care. reputed company’s headquarter is located in Charlotte, reputed company Carolina. The company’s shares are listed in the United States on reputed company under the symbol XRAY. Visit www.dentsplysirona.com for more information about reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company, and conclusions are adequately supported. Willingness to learn and adapt to new processes and technologies. Leadership experience reputed company medical device organizations. Key Leadership Behaviors: Actively articulates and promotes reputed company’s reputed company and direction. Advocates on behalf of the customer. Values driven with an insistence on reputed company. 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 reputed company across multiple reputed company, socio-geographic areas, and functional expertise. Resolves conflicts and fosters a positive working environment. Equal Opportunity Employer: reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will be considered without unlawful discrimination or regard for race, reputed company, religion, sex, sexual orientation, sexual or gender identity, national or ethnic reputed company, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility: reputed company 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 [email protected]. Agencies: Please note that reputed company 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 reputed company parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent reputed company is offering you a job, please have a look at the following information: careers.dentsplysirona.com. Apply To This Job