Top 612 Senior program specialist Jobs in Essex Ma

Senior Manager, Regulatory Affairs NAM
Straumann —Andover, MA
- Up to $145,000 a year
- Full-time
- 5 years
- Office
- Analysis skills
- Health insurance
- Dental insurance
Behavior Analyst (BCBA) - Hybrid
Autism Learning Partners —Burlington, MA
- $82,000 - $93,000 a year
- 8 hour shift
- Current TB test
- Mid-level
- Criminal background check
- Continuing education credits
- Disability insurance
Quick Apply
3d
Military Service - U.S. Air National Guard, Biomedical Equipment
Military Service - U.S. Air National Guard Recruiting —Massachusetts
- From $49,838.78 a year
- Full-time
- 18 years or older
- Military
- High school diploma or GED
- Health insurance
QUALITY ASSURANCE DIRECTOR
Flik Hospitality Group —Boston, MA
- $108,000 - $110,000 a year
- Full-time
- Background check
- 5 years
- Bachelor's degree
- Commuter assistance
- Paid parental leave
Quick Apply
In-Home Therapist (New Grads Welcome to Apply!)
Walker, Inc. —Boston, MA
- $75,000 a year
- Full-time
- Bilingual
- Outpatient experience
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
Engineering Specialist (DevOps) Lead
Fresenius Kabi —North Andover, MA
- $170,000 - $180,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- DevOps
- Wellness program
- Paid holidays
Quick Apply
Lead Specialist, International Trade Compliance
GE Aerospace —Lynn, MA
- $112,000 - $149,000 a year
- Full-time
- Pass drug screening
- Mid-level
- High school diploma or GED
- Paid parental leave
- Disability insurance
Military Service - U.S. Air Force, Flight Surgeon
Military Service - U.S. Air Force —Boston, MA
- From $57,088.25 a year
- Full-time
- Medicine
- Surgery
- 1 year
- Health insurance
MSL/Sr Medical Science Liaison - Hematology, Northeast
Genmab —Boston, MA
- $162,320 - $243,480 a year
- Online Application
- Medicine
- Up to 50% travel
- HIPAA
- Commuter assistance
- Paid parental leave
Manager or Senior Manager - Credits, Grants, and Incentives (AMCS)
KPMG —Boston, MA
- $105,640 - $223,100 a year
- Full-time
- Microsoft Excel
- Management
- CPA
- Disability insurance
- Health insurance
10d
Senior Underwriter, North America Fronting
Risk Specialists Companies Insurance Agency, Inc. —Boston, MA
- $80,000 - $100,000 a year
- Email
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
- Health insurance
Quick Apply
Community Manager
SENIOR CITIZENS HOUSING DEVELOPMENT CORPORATION OF BOSTON IN —Charlestown, MA
- $55,000 - $65,000 a year
- Full-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Buyer/Supply chain specialist
HarveyNash USA —North Reading, MA
- $25 - $33 an hour
- Contract
- Mid-level
- Office
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
8d
Senior Quantitative Portfolio Manager
MassMutual —Boston, MA
- $176,400 - $231,500 a year
- Full-time
- Research
- Office
- Finance
- Commuter assistance
- Paid holidays
Onsite Senior Technician
Custom Computer Specialists —Boston, MA
- $50,000 - $65,000 a year
- Full-time
- Microsoft Excel
- Mid-level
- Office
- Paid holidays
- Disability insurance
Quick Apply
Collections Specialist
Wayne Alarm Systems, Inc. —Lynn, MA
- $26 - $28 an hour
- Full-time
- Background check
- Research
- Office
- Health insurance
- Dental insurance
Quick Apply
Military Service - U.S. Air National Guard, Command and Control Operations
Military Service - U.S. Air National Guard Recruiting —Massachusetts
- From $49,838.78 a year
- Full-time
- High school
- English
- High school diploma or GED
- Health insurance
Program Specialist II
Honeywell Aerospace —Woburn, MA
- Full-time
- Hybrid work
- Mid-level
- Office
- Team management
3d
Senior Specialist, Program Scheduler
L3Harris Technologies —Wilmington, MA
- $84,000 - $156,000 a year
- Bachelor's degree
- Senior level
- 4 years
- Paid holidays
- Disability insurance
2d
International Trade Senior Specialist
Keurig Dr Pepper —Burlington, MA
- $95,000 - $120,000 a year
- Weekends as needed
- Remote
- 3 years
- Finance
- Analysis skills
- Mileage reimbursement
- Disability insurance

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Senior Manager, Regulatory Affairs NAM

Straumann -
Andover, MA

Apply Now

Job Details

Full-time
Up to $145,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Team leadership
Senior leadership

Full Job Description

#ChangeMakers

Ready to make an impact?

We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

#WeChangeDentistry every day. Be part of it.

Position Summary:

The Senior manager, Regulatory Affairs is responsible for developing and executing regulatory strategies for assigned product portfolios and projects across North America (US and Canada). This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams.

The Senior Manager provides strategic regulatory guidance to support product development, commercialization, and lifecycle management while ensuring compliance with FDA and Health Canada requirements. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.

Job Responsibilities:

This position is responsible for, but not limited to, the following:

Develop and execute regulatory strategies for assigned products and projects in alignment with North America and global regulatory objectives
Lead the planning, preparation, and submission of regulatory submissions (e.g., Pre-Submissions, 510(k)s, PMAs, IDEs, and Health Canada License Applications) to support product approvals and lifecycle management
Serve as the NAM regulatory representative on cross-functional project teams, providing guidance on regulatory requirements, risks, and timelines
Lead interactions with FDA and Health Canada reviewers for assigned submissions, including responding to questions and managing communications in alignment with leadership
Assess the regulatory impact of product changes and define appropriate regulatory pathways and documentation strategies
Review and approve regulatory documentation, including submissions, Memos-to-File, labeling, and promotional materials to ensure compliance with applicable regulations
Partner with global regulatory teams to ensure alignment on regulatory strategies, submissions, and change management activities
Monitor evolving regulatory requirements, guidance documents, and industry trends to inform regulatory strategy and maintain compliance
Contribute to regulatory intelligence activities, including competitive landscape assessments and interpretation of new regulations and standards
Support regulatory operations activities as needed, including establishment registrations, device listings, and import/export compliance
Manage the regulatory release of new products and address any regulatory import/export issues.
Ensure regulatory deliverables are completed in accordance with project timelines and quality expectations
Identify risks and proactively propose mitigation strategies to support successful regulatory outcomes
Monitor for and lead opportunities with FDA and Health Canada to participate in relevant pilot programs and Experiential Learning Programs.
May represent Regulatory Affairs in internal audits and support external inspections as needed
Directly manage, coach, and develop regulatory affairs staff, with full accountability for performance management, development planning, and team effectiveness
Develop and monitor appropriate metrics to track regulatory and process improvement.
Develop and deliver training regarding NAM Regulatory Affairs activities for Straumann Group globally and support cross-country projects as needed.
Other duties as assigned.

Management Responsibilities:

This position manages the following positions on a daily basis.

Direct: 1 to 3 Regulatory Affairs Specialists

Physical Attributes:

General office environment. May sit for extended periods of time.
Physically able to bend, crouch and reach continuously while performing required job tasks.
Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
Physically able to spend significant time reading both on paper and on a computer.
Travel less than 5% both domestically and internationally.

Minimum Qualifications:

Bachelor’s Degree in a scientific, engineering, or related discipline.
7-10 years of experience in a medical technology company with regulatory, quality, or clinical experience.
5+ years of people management or demonstrated team leadership experience

Preferred Qualifications:

Experience developing regulatory strategies and leading FDA and Health Canada submissions for all device classes
Strong working knowledge of FDA and Health Canada regulation and guidance
Experience negotiating and interfacing with FDA and Health Canada
Strong project management and organizational skills with the ability to manage multiple priorities
Excellent written and verbal presentation skills.
Strong analytical and problem solving skills with a solutions-oriented mindset.
Experience across multiple device types (e.g., capital equipment, consumables, implants, software as a medical device, etc.)

Salary: $128,00- $145,000/Annually. The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.

Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.

Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
A 401(K) plan to help you plan for your future with an employer match
Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
Generous PTO allowance - plenty of time to recharge those batteries!

Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.

Videos To Watch

https://youtu.be/3lq5BLAvIdQ

Unfortunately, we are currently seeing an increase in fraudulent job adverts and offers made third parties that pretend to represent our company offering unauthorized employment opportunities. Please be cautious and try to validate if the person communicating with you is a real Straumann Group company representative.

Tips for identifying a fraudulent messageOur Company will never ask for money as part of our recruitment process and will never make a job offer without a formal interview. We may contact you via text to schedule an interview; however, that text will always be accompanied by a corresponding email from one of our company's domains:

We may perform preliminary, candidate screening calls via telephone and as a company we mainly use Microsoft Teams for video meetings. Our Company does not interview candidates online using Signal, Google Hangout, AOL instant messenger or similar chat services.

We do not refer to our interviewers with official titles, such as Mr or Mrs.

If you have concerns, please check that the person contacting you is employed by Straumann Group, you’ll find their profile on Linkedin.

Our Company does not mail, electronically send, or wire any payments to prospective job candidates for them to purchase equipment for employment with us.

All resumes and applications are accepted officially online only, through our Careers Website

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time

Alternative Locations: United States : Andover (MA)

Travel Percentage: 0 - 10%

Requisition ID: 20647

Apply Now

Refine Your Search

senior program specialist jobs in essex ma

Senior Manager, Regulatory Affairs NAM

Behavior Analyst (BCBA) - Hybrid

Military Service - U.S. Air National Guard, Biomedical Equipment

QUALITY ASSURANCE DIRECTOR

In-Home Therapist (New Grads Welcome to Apply!)

Engineering Specialist (DevOps) Lead

Lead Specialist, International Trade Compliance

Military Service - U.S. Air Force, Flight Surgeon

MSL/Sr Medical Science Liaison - Hematology, Northeast

Manager or Senior Manager - Credits, Grants, and Incentives (AMCS)

Senior Underwriter, North America Fronting

Community Manager

Buyer/Supply chain specialist

Senior Quantitative Portfolio Manager

Onsite Senior Technician

Collections Specialist

Military Service - U.S. Air National Guard, Command and Control Operations

Program Specialist II

Senior Specialist, Program Scheduler

International Trade Senior Specialist

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