Regulatory Affairs Director jobs in New Hampshire

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director, US Regulatory Affairs
  • Sequel Medical Technology
  • Manchester, NH FULL_TIME
  • About Sequel
    Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

    Job Overview
    Reporting to the Vice President, Quality & Regulatory, the US Regulatory Affairs Director is responsible for driving regulatory affairs activities for the company, in compliance with the United States regulatory requirements.
    The scope of the role is expected to grow, as Sequel’s scope of activities might further evolve.

    Job Responsibilities and Essential Duties
    •  Advise the business on US regulatory strategy to ensure products meet the latest regulatory requirements for the US market.
    •  Support the cross-functional teams with the implementation of the necessary tools and processes to ensure compliance with QMSR and achieve business objectives.
    •  Perform promotional material review and approval for the regulatory affairs function to guarantee the alignment of external communication and claims to regulatory requirements.
    •  On an ongoing basis, educate and train cross-functional teams on applicable FDA requirements to ensure employees understand the regulatory framework and environment.
    •  Responsible for securing distribution rights across various U.S. states, with a focus on obtaining specific state licenses.
    •  Collaborate effectively with internal and external teams to:
    •  Ensure successful new product launches in the United States
    •  Develop strategies to ensure adherence to United States regulatory requirements across the company
    •  Prepare the team for interactions and negotiations with the FDA, including inspections
    •  Participate in compliance-related activities, including field action committee engagement
    •  Oversee regulatory intelligence for the U.S. market by monitoring, assessing, and communicating changes in U.S. regulations and guidance documents to ensure timely actions by cross-functional teams.

    Minimum Requirements
    •  Bachelor’s degree in life sciences preferred. Advanced degree with a focus on business or regulatory affairs strongly preferred.
    •  10 years of progressive experience in regulatory affairs, with a primary focus in medical device regulatory affairs.

    Required Knowledge, Skills and Abilities
    •  Comprehensive knowledge of and experience with of U.S. medical device regulations, Quality Management System Regulation, and Medical Device Software. Experience with electromechanical medical devices preferred.
    •  Demonstrated experience successfully meeting and negotiating with the FDA.
    •  Demonstrated experience preparing major regulatory submissions and supportive amendments or supplements.
    •  Experience in the field of convenience kits is a plus.
    •  Demonstrated ability to build strong cross-functional relationships to drive business needs. 
    •  Demonstrated negotiation and communication skills.

    Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    Environmental/Safety/Physical Work Conditions
    •  Ensures environmental consciousness and safe practices are exhibited in decisions
    •  Use of computer and telephone equipment and other related office accessories/devices to complete assignments
    •  May work extended hours during peak business cycles
    •  Physical requirements such as lifting specific weights
    •  Some travelling is expected
  • 18 Days Ago

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Regulatory Affairs Specialist II
  • Laborie
  • Portsmouth, NH FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
  • 10 Days Ago

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Senior Regulatory Affairs Specialist
  • Laborie
  • Portsmouth, NH FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
  • 13 Days Ago

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Regulatory Affairs Specialist II
  • Laborie Medical Technologies Corp
  • Portsmouth, NH FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
  • 23 Days Ago

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Regulatory Affairs Senior Associate (1042948)
  • The Judge Group
  • Newbury, NH CONTRACTOR
  • Location: Newbury Park, CA, USASalary: $30.00 USD Hourly - $37.00 USD HourlyDescription: Our client is currently seeking a Regulatory Affairs Senior AssociateDay to Day Responsibilities: Support the i...
  • 10 Days Ago

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Regulatory Affairs CMC Manager II
  • Lonza
  • Portsmouth, NH FULL_TIME
  • United States, Portsmouth (New Hampshire) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our gr...
  • 23 Days Ago

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

New Hampshire is part of the six-state New England region. It is bounded by Quebec, Canada, to the north and northwest; Maine and the Atlantic Ocean to the east; Massachusetts to the south; and Vermont to the west. New Hampshire's major regions are the Great North Woods, the White Mountains, the Lakes Region, the Seacoast, the Merrimack Valley, the Monadnock Region, and the Dartmouth-Lake Sunapee area. New Hampshire has the shortest ocean coastline of any U.S. coastal state, with a length of 18 miles (29 km), sometimes measured as only 13 miles (21 km). New Hampshire was home to the rock forma...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$172,785 to $246,090

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019