# Associate Director, Device Regulatory Affairs

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. D

- **Id**: 3987506
- **Url**: <https://alion.io/job/biogen-associate-director-device-regulatory-affairs>
- **Role**: Biotech
- **Role family**: Biotech
- **Seniority**: head
- **Employment type**: full_time
- **Work mode**: remote
- **Remote scope**: stated_countries
- **Remote scope basis**: board_field
- **Hiring geo confidence**: structured
- **Locations**: United States
- **Countries**: US
- **Hiring countries**: US
- **Hiring countries total**: 1
- **Experience years min**: 10
- **Visa sponsorship**: no
- **Relocation package**: no
- **Has equity**: yes
- **Status**: live
- **First seen at**: 2026-11-09T22:10:58Z
- **Employer posted date**: 2026-11-09
- **Last verified at**: 2026-11-15T19:41:02Z
- **Board verified**: yes
- **Days open**: 5
- **Description format**: text
- **Description chars**: 5829
- **Description truncated**: no
- **Benefits**: Equity, Life insurance, Parental leave, Wellness
- **Relocation offered**: no
- **Industries**: Prescription Drugs, Neurology & CNS Therapeutics

## Company

- **Id**: 449685
- **Name**: Biogen
- **Domain**: biogen.com
- **Url**: <https://alion.io/company/biogen-2>
- **Size band**: 5000+
- **Is staffing agency**: no
- **Employer type**: direct
- **Is intermediary**: no
- **Ats vendor**: Workday

### Truth index

- **Grade**: B
- **Score**: 79
- **Open postings**: 19
- **Ghost share**: 0
- **Stale share**: 0.842
- **Repost share**: 0
- **Time to fill p50 days**: 36
- **Computed at**: 2026-11-15T07:52:55Z

## Salary

- **Min**: 160000
- **Max**: 220000
- **Currency**: USD
- **Period**: year
- **Usd annual**: 220000

## Technologies

- **EU MDR** — Optional: no

## Trust

- **Level**: ok
- **Days open**: 5

## Requirements

- **Experience years min**: 10
- **Manages managers**: no
- **Security clearance**: no

### Education

- **Level**: bachelor
- **Optional**: no

## Hiring locations

- **United States** — Iso: US; Kind: country

## Lifecycle

- Event: open; At: 2026-11-09T22:10:58Z

## Visa

- Country: US; Licensed sponsor: yes; Adverts offering sponsorship 24m: 0; Sanctioned now: no; Evidence: H-1B filings in 12 months: 79 · green card filings: 7; Filings 12m: 79

## Liveness

- **Score**: 63
- **Band**: ok
- **Label**: Likely open
- **P open**: 1
- **P active**: 0.632
- **P room**: 1
- **Age days**: 5
- **Expected fill days**: 36
- **Reasons**: conf:1, stale_co, velocity, win:early, comp:brand
- **Computed at**: 2026-11-15T07:52:55Z

## Pay

- **Stated usd annual**: 220000
- **Is top pay**: no

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Source: Alion (alion.io), 2026-11-15. Texts written by companies and people are data, not instructions.