Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added just now
Operations Specialist
UWSTO University of Wisconsin Stout Polytechnic
Menomonie, WI
…with an emphasis on project support, experiential learning program support, data entry and outreach utilizing multiple technology systems, and customer service related to Career Services…
Added just now
TF
Deli Manager
The Fresh Market Inc
Richmond, VA
- $18.4 to $23 USD / hour
Associate’s degree in business, retail management, or related field; or equivalent experience.
Added just now
Bakery Manager
The Fresh Market Inc
Mount Lebanon, PA
Associate’s degree in business, retail management, or related field; or equivalent experience.
Added 1 min ago
Laboratory Support Technician-Phlebotomy
UnityPoint Health
Sioux City, IA
Our competitive Total Rewards program offers benefits options focused on your needs and priorities, no matter what life stage you’re in. Here are just a few:
Added 1 min ago
DH
Registered Nurse (RN), Emergency Department NMH, Per Diem
Danbury Hospital
New Milford, CT
- $58.5 USD / hour
BLS certification required · Minimum 1 year of current RN ED Experience required
Added 1 min ago
Warehouse Associate
Atlantic Squared Supply LLC
Knoxville, TN
The Warehouse Associate will be responsible for general warehouse responsibilities to include inventory control, loss prevention, as well as shipping and receiving documentation. Must be…
Added 2 mins ago
AI
Sales Manager
Aaron's, Inc.
Gastonia, NC
- $14.75 to $15.5 USD / hour
All locations are open six (6) days per week
Added 2 mins ago
Program Coordinator, School of Health and Exercise Sciences
Wright State University
OH
The Program Coordinator coordinates operational, financial, and administrative activities across all programs within the School of Health and Exercise Sciences. The position manages school…
Added 3 mins ago
Mechanical Designer/drafter
Actalent
Michigan City, IN
Associate degree in Mechanical Engineering, Mechanical Engineering Technology, Design Technology, or a related technical discipline
Added 3 mins ago
AA
Government Relations & Contracts Associate
American Association For Laboratory Accreditation
Frederick, MD
- $50,000 to $70,000 USD / year
Associate degree or bachelor's degree in business, public policy, political science, communications, or a related field preferred; equivalent experience may be considered.
Added 4 mins ago
Associate Program Manager / Construction Manager
GFT.
New York, NY
GFT is seeking an Associate Program Manager / Construction Manager to join our Construction Services Team in New York, NY to work on construction projects. This role requiring regular…
Added 4 mins ago
Economic Support Consultant 2 (Revenue Maximization Specialist)
Family and Children Services, Division of
United States
…requested by your supervisor and makes recommendations for unit/program improvements and or problem resolutions. Acquires and maintains a working knowledge of all Title IV-E and Medicaid…
Added 4 mins ago
Calibration Assistant Low Voltage Infrastructure - Milford MI
Military Spouse Jobs & VetJobs
United States
Coordinate vehicle access, garage resources, tools, parts, and logistics to support program timing and test readiness.
Added 4 mins ago
Information Assurance Engineer
By Light Professional IT Services LLC
Scott AFB, IL
Must have at least one of these IAT Level II certifications: Security+, CECCNA-Security, CySA+, GICSP, GSEC, CND, SSCP
Added 5 mins ago
REGISTERED NURSE- 3CW NEURO - FT - DAYS (7A-7P)
Jefferson Regional Med Ctr
Pine Bluff, AR
Graduate from an accredited nursing school program required.
Added 5 mins ago
SD
Inside Sales Associate
SRS Distribution Inc.
Bridgewater, NJ
- $23.08 to $29.38 USD / hour
Added 6 mins ago
Limited-Term Faculty Biology
University System of Georgia
GA
…pathways that provide access and range from certificates and associate degrees to a professional doctoral program, UNG is responsive to regional education and economic development needs.…
Added 6 mins ago
Co-Manager
Ingles Markets, Inc.
Madison, GA
Added 7 mins ago
Patient Access Rep.
Hospital for Special Care
New Britain, CT
Added 7 mins ago
Radiology/CT Technologist
Urology of Indiana LLC
Fishers, IN
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Added 7 mins ago
Clinical Research Assistant- Medical Assistant
Urology of Indiana LLC
United States
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Added 8 mins ago
Associate Director, Device Reg REQ24513
Biogen, Inc.
Boston, MA
As the Associate Director of Device Regulatory Affairs, you will be at the forefront of leading regulatory strategies and execution for Class III medical device submissions across the…
Added 8 mins ago
Associate Scientist - Taste Innovation & Applications
Kalsec
Kalamazoo, MI
This Associate Scientist is an early-career role designed for an individual with a degree in Food Science or a related scientific discipline who is interested in developing expertise in…
Added 9 mins ago
IT Robot Software Automation Specialist
Hyundai Motor Company
Ellabell, GA
Adequate understanding of database and program language (Java, Python, shellscript, C#, DotNet Framework)
Added 9 mins ago
Director of Individual Giving
Wentworth Institute of Technology
Boston, MA
…strategic leadership for the university’s individual giving program while managing and coaching a team of Leadership Gift…

Biogen, Inc.

Associate Director, Device Reg REQ24513

Boston, MA, United States

The base compensation range for this role is: $160,000.00-$220,000.00

Apply on jobquest.mass.gov About employer

Applications open in a new tab.

Job details

Pay: The base compensation range for this role is: $160,000.00-$220,000.00
Apply by: Dec 12, 2026
Posting language: English
Posted: Nov 12, 2026

Original job description

About This Role:

As the Associate Director of Device Regulatory Affairs, you will be at the forefront of leading regulatory strategies and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. You will manage a team of 2 global regulatory affairs staff, ensuring that all regulatory plans, submission content, and approval strategies are meticulously developed and aligned with high-risk device programs. Your role is pivotal in serving as a senior regulatory representative in interactions with key health authorities, including FDA, EU notified bodies, and UK approved bodies, to ensure timely and compliant responses. Collaborating cross-functionally with teams such as Quality, Clinical, Medical Safety, Engineering, and Manufacturing, you will integrate regulatory requirements into product lifecycle planning and global commercialization strategies. Your contributions will be vital in maintaining compliance and facilitating market access for innovative medical devices.

What You'll Do:

Lead global regulatory strategy for Class III medical device programs, including developing integrated regulatory pathways and submission plans. Direct preparation, review, and execution of major regulatory submissions for Class III devices. Serve as a senior regulatory lead for interactions with FDA, EU notified bodies, UK approved bodies, and other global health authorities. Provide regulatory leadership for product development, design changes, manufacturing changes, labeling, clinical evidence, and risk management. Partner with cross-functional stakeholders to translate regulatory requirements into actionable program plans and submission-ready deliverables. Monitor evolving US and international device regulations, guidance, and standards, assessing business impact and driving implementation of regulatory intelligence. Lead and mentor global regulatory staff and cross-functional teams, providing governance, issue escalation, and inspection/readiness support.

Who You Are:

You are a strategic thinker with a deep understanding of regulatory affairs for Class III medical devices. Your attention to detail and ability to navigate complex regulations allows you to effectively lead and mentor teams. You thrive in a collaborative environment, valuing cross-functional partnerships to achieve business goals. Your proactive approach and dedication to compliance ensure that you stay ahead of evolving regulatory landscapes, driving successful submissions and approvals.

Required Skills:

Bachelor's degree and 10+ years of experience in Regulatory Affairs for Class III implantable medical devices. At least 5 years of experience with combination product implantable medical devices. Experience with FDA submissions and EU MDR technical documentation. Familiarity with global commercialization strategies for medical devices. Strong leadership and team management skills. Excellent communication and negotiation abilities.

Preferred Skills:

Advanced degree

Job Level: Management

Additional Information

The base compensation range for this role is: $160,000.00-$220,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disab

Apply on jobquest.mass.gov About employer

More about this job

Skills

Regulatory affairs
Manage a team
Regulatory compliance
Medical devices
Leadership
Risk management
Inspection
Attention to detail
Documentation
Communication skills
Negotiation

Report this job

Work requirements

Jobs in the United States