Katalyst CRO ยท 2 days ago
Regulatory Affairs Manager
Boston, MA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a Regulatory Affairs Manager to oversee the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. The role involves developing regulatory strategies for medical devices, managing communications with the FDA, and mentoring regulatory affairs professionals.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions 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
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, succession planning
Complies with company and departmental policies and administrative requirements
Performs other duties as assigned or as needed
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
Resolves conflicts and fosters a positive working environment
Qualification
Required
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)
Proficiency with Microsoft Office Suite
Proficiency with Regulatory software
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
Strong results orientation and analytical skills
Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise
Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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