Regulatory Affairs Director jobs in Lawrence, MA

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, Regulatory & Quality Affairs
  • MDC Associates
  • Beverly, MA FULL_TIME
  • The Director of Regulatory & Quality Affairs will be a critical team member supporting MDC's regulatory and quality affairs business and support client RA/QA strategy and regulatory submissions. The primary role and responsibilities include managing RA/QA business and personnel, and the development of regulatory strategies. submissions, and communicating with clients and regulatory bodies. The Director collaborates closely with MDC's executive management team to ensure the growth and success of the company's RA/QA business.

    Responsibilities

    • Direct and coordinate MDC’s Regulatory Affairs activities
    • Collaborate with other MDC departments including Clinical Affairs and Quality Systems to ensure continuity of service across client projects
    • Support business development secure new clients and project
      • Participate in client meetings and assist with developing project scope of work, resource requirements, and pricing for client proposals
    • Directly engage in client projects to provide:
      • Regulatory guidance and strategy
      • Develop regulatory submissions including FDA registration & listings, 510(k), de novo, Pre-Market Authorization (PMA) and submissions to Notified Bodies under IVDR.
      • Develop strategy and actively engage with regulatory bodies to achieve approval of all submissions and filings
    • Ensure department activities and resources associated with filings are dedicated to meeting client expectations 
    • Implement systems to support continual improvement of Regulatory Affairs services and support long-term growth of the business
    • Recruit, hire, train and coach Regulatory Affairs staff and team members
    • Develop and achieve Regulatory Affairs department Long-Range Plans and annual Objectives and Key Results (OKRs)
    • Participate in monthly management team meetings and provide regular updates on department LRP and OKRs progress
    • Assist with developing and achieving MDC’s Corporate LRP and OKRs

    Qualifications

    • Bachelor’s degree in a scientific discipline; Master of Science or PhD a plus
    • Minimum of 10 years of experience in Regulatory Affairs related to development of medical devices/IVDs.
    • Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies (i.e., FDA) and clients.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication and presentation skills.
    • Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them.
    • Strong research, analytical and problem-solving skills.
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
    • Must be punctual, polished, and professional.
    • Ability to lead a team and mentor junior Regulatory Team members.
    • Strong professionalism with customer relations and managing client relationships

    About MDC

    For over 35 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.

    By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.

    Travel Requirements

    15-25% Travel including local, within U.S and outside of the US. Travel may include:

    • Attending off-site client meetings o Attending clinical Site Initiation Visits
    • Attending FDA Meetings (i.e: Pre-Submission Meeting, Submission Issue Meetings, etc.)
    • Attending annual industry conferences 

    Pay & Benefits:

    • Salary  Bonus
    • 401(k) w/ match
    • Equity incentive program
    • Medical, Dental, and Vision Insurance
    • Flexible Spending / Dependent Care Accounts
    • STD/LTD/GTL/VTL
    • Generous PTO / Sick time policy

  • 18 Days Ago

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Regulatory Affairs Specialist
  • Johnson & Johnson
  • Danvers, MA FULL_TIME
  • Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company Abiomed, p...
  • 1 Day Ago

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Senior Regulatory Affairs Specialist
  • ABIOMED Inc.
  • Danvers, MA FULL_TIME
  • Job Title Senior Regulatory Affairs Specialist Function Regulatory Affairs Group Sub Function Regulatory Affairs Location Danvers, MA, United States; United States Date Posted Feb 29 2024 Requisition ...
  • 7 Days Ago

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Regulatory Affairs III Associate
  • RQMIS
  • Amesbury, MA FULL_TIME
  • Our Mission RQMIS’ mission is to bring about safe and effective medical devices and biotechnology products by assisting companies in navigating the regulatory process and addressing governmental requi...
  • 12 Days Ago

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Regulatory Affairs Co-op
  • ABIOMED Inc.
  • Danvers, MA FULL_TIME
  • Job Title Regulatory Affairs Co-op Function Career Programs Sub Function Non-LDP Intern/Co-Op Location Danvers, MA, United States Date Posted Feb 02 2024 Requisition Number 2406167797W Description Abi...
  • 1 Month Ago

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Regulatory Affairs Specialist II
  • BioTalent
  • Andover, MA FULL_TIME
  • Regulatory Affairs Specialist II BioTalent Andover, MA About the job BioTalent is partnered with a cutting edge medical device manufacturer seeking a driven Regulatory Affairs Specialist to join their...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Lawrence, MA area

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Lowell, MA
  • Catalyst Life Sciences is partnered with a medical device company seeking an experienced leader in international regulat...
  • 3/28/2024 12:00:00 AM

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Director, GRA CMC Pharmaceuticals, Oligonucleotides
  • Takeda Pharmaceutical
  • Boston, MA
  • By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the...
  • 3/28/2024 12:00:00 AM

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Program Manager - Regulatory and Accreditation Programs
  • Beth Israel Lahey Health
  • Boston, MA
  • When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. Job Typ...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Atrium Medical
  • Hudson, NH
  • Position Specific Requirements: Responsible for internal, domestic, and international compliance activities working unde...
  • 3/27/2024 12:00:00 AM

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Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)
  • BioNTech SE
  • Cambridge, MA
  • Become a member of the BioNTech Family! Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the h...
  • 3/26/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Dyne Therapeutics
  • Waltham, MA
  • Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-tran...
  • 3/25/2024 12:00:00 AM

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Director, Regulatory Affairs
  • Cellarity
  • Somerville, MA
  • What if you could join a company rapidly advancing its first candidate to clinic and play a critical role in bringing ne...
  • 3/25/2024 12:00:00 AM

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Senior Director of Regulatory Affairs
  • Scienta
  • Boston, MA
  • The Company A clinical-stage biotech focused on Auto-Immune Diseases. This company utilizes antibodies to harness the bo...
  • 3/24/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 7.4 square miles (19 km2), of which 7.0 square miles (18 km2) is land and 0.4 square miles (1.0 km2) (6.07%) is water. Lawrence is on both sides of the Merrimack River, approximately 26 miles (42 km) upstream from the Atlantic Ocean. On the north side of the river, it is surrounded by Methuen. On the south side of the river, the town is bordered by North Andover to the east, and Andover to the south and southwest. Lawrence is approximately 30 miles (48 km) north-northwest of Boston and 27 miles (43 km) southeast of Manc...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$180,000 to $256,359
Lawrence, Massachusetts area prices
were up 1.6% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020