Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added just now
VP, Enterprise Sales, Payables, New England
Corpay
Boston, MA
Reporting directly to the Senior Vice President, Enterprise Sales, this individual will partner closely with Marketing, Product, Revenue Operations, Solutions Consulting, Customer Success,…
Added just now
VP, Enterprise Sales, Payables, Southeast (TN)
Corpay
Brentwood, TN
Reporting directly to the Senior Vice President, Enterprise Sales, this individual will partner closely with Marketing, Product, Revenue Operations, Solutions Consulting, Customer Success,…
Added just now
AR
Assisted Confirmation Pathways Associate
American Red Cross
Statewide, MT
- $60,000 to $75,000 USD / year
Experience: Minimum 3 years of related experience or equivalent combination of education and related experience required
Added just now
Sr Project Controls Professional (Data Center)
Jacobs
Billings, MT
Track and report on construction physical progress using Earned Value Management (EVM).
Added just now
Lead Director - Security Operations Center (SOC)
CVS Health
Helena, MT
Support regulatory, audit, and risk management activities related to cybersecurity operations.
Added just now
Senior Director Software Engineering
Capital One
Helena, MT
…working to define the future of banking in the cloud. You will partner closely with product managers, designers, architects and executive leaders to deliver scalable, customer-centric…
Added just now
Senior Manager, Sales Operations
Parexel
Helena, MT
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we…
Added just now
Executive Officer
State of Montana
Helena, MT
* *Note: Employees for the State of Montana must reside within Montana
Added just now
Contracts Specialist
GE Aerospace
Helena, MT
The GE Aerospace’s Contracts team is a critical team member, and a trusted and proactive business partner to the product lines within the business. Contracts is the face of GE Aerospace to…
Added just now
Companion Animal Territory Representative - Mooresville, NC / Winston-Salem, NC
Merck
Helena, MT
Develop customer strategy - outlining strategy for interactions/relationship, solutions, partner involvement and potential offerings for customers resulting in solutions, partner…
Added just now
Product Security Engineer - Team Lead
Meta
Helena, MT
…security). You will be working closely with product teams and partner security organizations to define strategy, build security tooling, and ship secure-by-design product functionality for…
Added just now
Vice President of Technical Presales
Siemens
Helena, MT
…shape customer strategy, unify a multidisciplinary team, and partner directly with R&D and Product Management to influence product direction through evidence from the…
Added just now
VP – Software Delivery
Maximus
Helena, MT
…performance, strategic planning, contracting actions, subcontractor management, human resources assignments, recruiting, hiring, financial management, budgeting, and business…
Added just now
Executive Administrative Partner
Meta
Helena, MT
Meta is seeking an experienced Executive Administrative Partner to support Directors in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an…
Added just now
Manager Internal Audit
HCSC
Helena, MT
This is a Flex (Hybrid) role: 3 days in office; 2 days remote
Added just now
Hardware Systems Architect, AI Hardware Products
Meta
Helena, MT
Guide management and partner teams on long-term technology investments
Added 1 min ago
Field Representative II, Print Support
Ricoh
Berwick, PA
…Responsibilities may include the procurement of printer hardware and the management of an on-site parts/consumables…
Added 1 min ago
Senior On-Site Service Specialist
Ricoh
El Paso, TX
· Maintains records for management reports and inventories of supplies needed.
Added 1 min ago
Inside Sales Office Solutions Specialist
Ricoh
Fenton, MO
Hybrid work environment; must have the capability to work remotely
Added 1 min ago
Senior Office Solutions Specialist
Ricoh
Fenton, MO
Hybrid work environment; must have the capability to work remotely
Added 1 min ago
Program Instructor
Goodwill Industries Of Upstate/Midlands South Carolina, Inc
Greenville, SC
Develop and sustain relationships with partner banks, financial institutions, recruiters, and hiring managers to keep the program aligned with changing branch roles and employer needs, and…
Added 1 min ago
Procurement Director
CRH
Atlanta, GA
Strong planning, project management, problem-solving, and team-development skills.
Added 1 min ago
Regional Service Operations Manager
Rivian
Seattle, WA · Fife, WA · Bellevue, WA · Tualatin, OR · Portland, OR
…standards of performance and operational excellence, as well as management of regional operations. Areas requiring direct oversight by this role will include vendor management, risk…
Added 2 mins ago
IS
Project Manager IV
INSPYR Solutions
Remote Location, NY
- $52 to $72 USD / hour
We are looking for a Project Manager IV with strong experience in project management, brand operations, and digital website or portal management. This role will support high-volume…
Added 2 mins ago
Experience Research & Design Team Lead
INSPYR Solutions
Fort Worth, TX
Location: Fort Worth, TX 76109 zip code (Hybrid role, onsite 3 days per week)

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