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Edwards Lifesciences
Boston
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention
Job Source: Edwards LifesciencesHarvard University
Cambridge
66247BRAuto req ID:66247BRJob Code:CM0359 Public/Media Rltn Mgmt II Department Office Location:USA - MA - Cambridge Business Title:Senior Manager for Intergovernmental Policy and Regulatory AffairsSub-Unit: Salary Grade (arvard.edu/salary-ranges#ranges) :059Time Status:Full-time Union:00 - Non Union, Exempt or Temporary Basic Qualifications: + Bach
Job Source: Harvard UniversityBrigham and Women's Hospital
Somerville, MA, United States
Job Description - Sr. Regulatory Affairs Manager (3291838) Sr. Regulatory Affairs Manager - ( 3291838 ) Mass General Brigham Health Plan is an exciting place to be within the healthcare industry. As a member of Mass General Brigham, we are on the forefront of transformation with one of the world’s leading integrated healthcare systems. Together
Job Source: Brigham and Women's HospitalThe Ladders
Somerville, MA, United States
Mass General Brigham Health Plan is an exciting place to be within the healthcare industry. As a member of Mass General Brigham, we are on the forefront of transformation with one of the world's leading integrated healthcare systems. Together, we are providing our members with innovative solutions centered on their health needs to expand access to
Job Source: The LaddersThermo Fisher Scientific
Watertown, MA, United States
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solvin
Job Source: Thermo Fisher ScientificThermo Fisher Scientific
Waltham, MA, United States
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, s
Job Source: Thermo Fisher ScientificCitizens Financial Group, Inc.
Boston, MA, United States
Description As Senior Manager of the Citizens Financial Group Compliance Regulatory Relations team, this individual is responsible for managing the relationship, examination activity, and facilitating all other interactions, including the flow of information to and from the following regulatory agencies with respect to Citizens: the Federal Reserv
Job Source: Citizens Financial Group, Inc.Moderna
Cambridge, MA, United States
The Role: Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward-looking, creative, and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as an unprecedented new
Job Source: ModernaWaltham
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
Position Summary
Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG). The main activities revolve around developing and maintaining the team's capabilities for regulatory activities that support the LPE business portfolio throughout its product life cycle. Delivering strategic and tactical regulatory support to the business and project teams is a crucial aspect in assisting the Company in achieving its business goals. The incumbent will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a member of the LPE leadership team.
Responsibilities
Responsible for developing strategies, systems, and processes to ensure a high level of regulatory compliance within LPE.
Responsible for leading and developing the global RA team supporting LPE.
Responsible for reviewing and providing guidance to the business related to regulatory requirements for LPE product development and registrations (e.g., ISO, FDA, IVDD/IVDR, MDD/MDR), as well as product safety and regulatory compliance.
Overseeing the regulatory submission to regulatory agencies, notified bodies and certification bodies and ensure timely approval.
Oversight of product compliance test (conditions, EMC, safety etc.) planning and coordination. Responsible for signing EC Declaration of Conformities for regulated and electronics products and Quality Certificates when applicable.
Responsible for understanding and interpreting changes in regulatory standards and/or requirements for the business from different countries and regions.
Work closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is completed.
Supports internal and external QMS audits and providing support for Management Reviews as needed.
Minimum Requirements/Qualifications
+ Bachelor's degree in engineering or science discipline, advanced degree is plus
+ 8+ years of work experience in regulatory and compliance field, familiar with working with regulatory authorities globally
+ Five years of people management experience
+ Strong communication skills
+ Attention to details
+ Comfortable working in a matrixed environment
**Benefits:**
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
**Compensation and Benefits**
The salary range estimated for this position based in New York is $118,100.00–$177,200.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: hermofisher.com/global/en/total-rewards
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Email Alert for Sr Manager, Regulatory Affairs_ jobs in Waltham
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