Top 1009 Regulatory specialist Jobs in Waltham, Ma

Regulatory Affairs Specialist I
Philips —Bedford, MA
- $63,000 - $112,000 a year
- Full-time
- Research
- Office
- Databases
- Health savings account
- Employee stock purchase plan
Physical Therapist - (SIGN ON BONUS!) Watertown, MA
FOX Rehabilitation —Watertown, MA
- $70,000 - $110,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
Registered Nurse (RN), Oncology
AMN Healthcare —Cambridge, MA
- $42.65 - $105.81 an hour
- Full-time
- Nursing
- RN License
- Bachelor of Science
- Relocation assistance
4d
Assistant Underwriter- Client Specialist III (Hybrid)
Quincy Mutual Group, Inc. —Quincy, MA
- $58,000 - $62,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Writing skills
- Office
- Health savings account
- Health insurance
Quick Apply
RN Manager
Lynn Community Health Center —Lynn, MA
- $80,000 - $95,000 a year
- Full-time
- Spanish
- Nursing
- RN License
Quick Apply
Medical Technologist Specialist, Hematology (Days)
Boston Medical Center —Boston, MA
- $40 - $52 an hour
- 8 hour shift
- 5 years
- English
- Bachelor's degree
- Disability insurance
- Health insurance
Quick Apply
LPN (Brain Injury)
Vinfen —Braintree, MA
- $38.44 an hour
- Full-time
- Bilingual
- Background check
- CPR Certification
Quick Apply
Coding and Compliance Auditor
South Shore Health —Weymouth, MA
- Full-time
- Hybrid work
- 5 years
- Mid-level
- Acute care experience
Quick Apply
Registered Nurse Case Manager, RN
South Shore Support Services —Hingham, MA
- $40 an hour
- Part-time
- Microsoft Word
- Background check
- Experience working with individuals with developmental disabilities
- Health insurance
- Dental insurance
Quick Apply
Hardware Applications Managment Technical Specialist, Applied Automation
Amazon.com Services LLC —North Reading, MA
- $148,700 - $201,200 a year
- Full-time
- 5 years
- Product management
- Senior level
- AD&D insurance
- Health insurance
4d
Physical Therapist - Weston, MA
FOX Rehabilitation —Weston, MA
- $70,000 - $110,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
2d
Licensed Practical Nurse (LPN) (Brain Injury)
Vinfen —Braintree, MA
- $38.44 an hour
- Full-time
- Background check
- Clean driving record
- Computer literacy
Quick Apply
Physical Therapist - Quincy, MA
FOX Rehabilitation —Quincy, MA
- $70,000 - $110,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
2d
Regulatory Affairs Spec
Draeger Medical Systems, Inc. —Andover, MA
- $84,100 - $100,900 a year
- Hybrid work
- Bachelor of Science
- Research
- Mid-level
- Free parking
- Paid holidays
Commercial Loan Workout Specialist
First Technology Federal Credit Union —Marlborough, MA
- $61,000 - $79,500 a year
- Email
- Mid-level
- Office
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
5d
Registered Respiratory Therapist
Eteam Healthcare —Boston, MA
- $50 - $55 an hour
- Rotating shift
- Anatomy knowledge
- Vital signs
- PALS Certification
Quick Apply
Physical Therapist - (SIGN ON BONUS!) Wrentham, MA
FOX Rehabilitation —Wrentham, MA
- $70,000 - $110,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
Reform Physical Therapy Physical Therapist — Part-Time or Full-Time
Reform Physical Therapy —Natick, MA
- $80,000 - $90,000 a year
- 8 hour shift
- Physical & Rehabilitation Medicine
- Mid-level
- Outpatient experience
- Free parking
- Continuing education credits
Quick Apply
Occupancy Specialist
Barkan Management Company —Brighton, MA
- $28 - $31 an hour
- Customer service
- Mid-level
- Residential
Quick Apply
9d
RN ED Case Manager per diem
South Shore Health —Weymouth, MA
- $59.42 - $86.20 an hour
- Part-time
- Acute care
- Nursing
- Patient monitoring
2d

I want to receive the latest job alert for regulatory specialist in waltham, ma

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory specialist jobs near waltham, ma

Respiratory Therapist jobs in Boston, MA

Physical Therapist jobs in Natick, MA

Physical Therapist jobs in Weston, MA

Physical Therapist jobs in Wrentham, MA

Loan Specialist jobs in Marlborough, MA

Licensed Practical Nurse jobs in Braintree, MA

Physical Therapist jobs in Quincy, MA

Regulatory Affairs Specialist jobs in Bedford, MA

Physical Therapist jobs in Watertown, MA

Registered Nurse Case Manager jobs in Hingham, MA

Registered Nurse Case Manager jobs in Weymouth, MA

Occupational Therapist jobs in Riverside, CA

Physical Therapist jobs in Sioux Falls, SD

Respiratory Therapist jobs in Aiken, SC

Respiratory Therapist jobs in West Palm Beach, FL

Respiratory Therapist jobs in Los Angeles, CA

Respiratory Therapist jobs in Kansas

Respiratory Therapist jobs in Mesa, AZ

Physical Therapy Aide jobs in Atlanta, GA

Physical Therapist jobs in Boca Raton, FL

Regulatory Affairs Specialist I

Philips -
Bedford, MA

Apply Now

Job Details

Full-time
$63,000 - $112,000 a year

Benefits

Health savings account
Employee stock purchase plan
401(k)
Tuition reimbursement
Paid time off
401(k) 7% Match
401(k) matching

Qualifications

Research
Bachelor's degree
Biomedical regulatory compliance
Stakeholder relationship building

Full Job Description

Job Title

Regulatory Affairs Specialist I

Job Description

The Regulatory Affairs Specialist I supports regulatory activities to help ensure Philips Image Guided Therapy Devices are safe, effective, and compliant with applicable global regulatory requirements. This role also provides an excellent opportunity to develop expertise in medical device regulations, including FDA regulations, EU MDR requirements, and international regulatory processes.

Your role:

Support preparation, review, and maintenance of regulatory documentation for medical device products.
Assist with regulatory submissions, registrations, renewals, and product change assessments under the guidance of senior regulatory professionals.
Contribute to the development and maintenance of Technical Documentation and Design History Files to support regulatory compliance.
Research and interpret regulatory requirements, standards, guidance documents, and industry best practices.
Partner with cross-functional teams including Quality, R&D, Clinical, Marketing, Manufacturing, and Supply Chain to ensure regulatory requirements are understood and implemented.
Support regulatory activities throughout the product lifecycle, including product development, design changes, and post-market surveillance.
Assist in preparing responses to regulatory authority requests and audit observations.
Participate in internal audits, quality management system activities, and inspections as needed.
Support international market registrations and regulatory compliance activities for regions such as the United States, European Union, Canada, Japan, and other global markets.
Monitor regulatory changes and communicate relevant updates to internal stakeholders. Help maintain regulatory records, databases, and submission tracking tools.
Participate in continuous improvement initiatives to enhance regulatory processes and compliance effectiveness.

You're the right fit if:

You've acquired a minimum of 1+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments with experience/exposure to 510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions.
You have knowledge in Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971) and experience with SaMD (IEC 82304) is preferred.
You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.
You have Proficiency with Microsoft Office applications.
You’re able to build strong relationships with internal/external stakeholders, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
You have a minimum of a Bachelors’ Degree (Required) in Regulatory Affairs, a Scientific or Technical discipline (Engineering, Biology, Biomedical Engineering, Pharmacy, Chemistry) or similar disciplines.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

How we work together:

We believe that we are better together than a part. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office-Based role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business .
Discover our rich and exciting history.
Learn more about our purpose.
Learn more about our culture.

Philips Transparency Details:

The pay range for this position in Bedford, MA and San Diego, CA is $71,000 to $112,000.
The pay range for this position in Plymouth, MN is $67,000 to $105,000.
The pay range for this position in Colorado Springs, CO is $63,000 to $100,000.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

Additional Information:

US work authorization is a precondition of employment. The company WILL NOT CONSIDER CANDIDATES WHO REQUIRE SPONSORSHIP FOR A WORK AUTHORIZED VISA NOW OR IN THE FUTURE.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA, Plymouth, MN, San Diego, CA or Colorado Springs, CO.
May travel up to 10%

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Apply Now

Refine Your Search

regulatory specialist jobs in waltham, ma

Regulatory Affairs Specialist I

Physical Therapist - (SIGN ON BONUS!) Watertown, MA

Registered Nurse (RN), Oncology

Assistant Underwriter- Client Specialist III (Hybrid)

RN Manager

Medical Technologist Specialist, Hematology (Days)

LPN (Brain Injury)

Coding and Compliance Auditor

Registered Nurse Case Manager, RN

Hardware Applications Managment Technical Specialist, Applied Automation

Physical Therapist - Weston, MA

Licensed Practical Nurse (LPN) (Brain Injury)

Physical Therapist - Quincy, MA

Regulatory Affairs Spec

Commercial Loan Workout Specialist

Registered Respiratory Therapist

Physical Therapist - (SIGN ON BONUS!) Wrentham, MA

Reform Physical Therapy Physical Therapist — Part-Time or Full-Time

Occupancy Specialist

RN ED Case Manager per diem

I want to receive the latest job alert for regulatory specialist in waltham, ma

Related Searches

Explore jobs in more locations

Job Title

Job Description

Job Seeker Tools

Employer Tools

Browse

Stay Connected