We have other current jobs related to this field that you can find below
-
Regulatory Affairs Consultant
3 months ago
Beverly, United States MDC Associates Full timeJob DescriptionJob DescriptionAs a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. You will be responsible for the overall planning of regulatory activities and in addition provide input on clinical study design and reports for our CRO services team. You will develop and...
-
Regulatory Affairs Specialist
6 days ago
Beverly, Massachusetts, United States MDC Associates Full timeJob OverviewAs a Regulatory Affairs Consultant, you will spearhead regulatory initiatives and offer expert guidance to manufacturers of in vitro diagnostic (IVD) devices. Your role will encompass the comprehensive planning of regulatory activities, along with providing insights on clinical study design and documentation for our Clinical Research Organization...
-
Regulatory Affairs Specialist
6 days ago
Beverly, Massachusetts, United States MDC Associates Full timeJob OverviewAs a Regulatory Affairs Consultant, you will spearhead regulatory initiatives and offer expert guidance to manufacturers of in vitro diagnostic (IVD) devices. Your role will encompass comprehensive planning of regulatory activities while also contributing to the design and reporting of clinical studies in collaboration with our Clinical Research...
-
Beverly, Massachusetts, United States BioTalent Full timeBioTalent is collaborating with a cutting-edge medical device company specializing in advanced laser and imaging technologies. In this role, you will oversee the production of class III medical devices while guiding a dedicated team through Quality Assurance and Regulatory Affairs initiatives.Key ResponsibilitiesEnsure compliance of all products and...
-
Quality Regulatory Manager
4 weeks ago
Beverly, United States BioTalent Full timeBioTalent is partnered with a medical device manufacturer focusing on next-generation technology focusing on laser and imaging tech. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.ResponsibilitiesEnsure that all products and processes comply with applicable regulatory requirements (e.g., FDA,...
-
Quality Regulatory Manager
4 weeks ago
Beverly, United States BioTalent Full timeBioTalent is partnered with a medical device manufacturer focusing on next-generation technology focusing on laser and imaging tech. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.ResponsibilitiesEnsure that all products and processes comply with applicable regulatory requirements (e.g., FDA,...
-
Clinical Trials Coordinator
22 hours ago
Beverly, Massachusetts, United States MDC Associates Full timeJob OverviewAs a Clinical Research Associate, you will be a key facilitator between clinical trials and the generation of valuable clinical data. Your role will involve leading the identification, assessment, and establishment of clinical study sites for in-vitro diagnostic medical devices.This position offers a unique opportunity to significantly contribute...
-
Clinical Research Associate
2 months ago
Beverly, United States MDC Associates Full timeJob DescriptionJob DescriptionAs a Clinical Research Associate you will serve as the pivotal link between clinical studies and robust clinical data. You’ll lead efforts to identify, evaluate, and establish clinical study sites for in-vitro diagnostic medical devices.You have an opportunity to play a crucial role in making the latest diagnostic tests and...
-
Clinical Trials Coordinator
22 hours ago
Beverly, Massachusetts, United States MDC Associates Full timeJob OverviewAs a Clinical Research Associate, you will act as a crucial intermediary between clinical trials and comprehensive clinical data. Your role will involve spearheading efforts to identify, assess, and establish clinical study sites for in-vitro diagnostic medical devices.This position offers you the chance to significantly contribute to the rapid...
-
Clinical Trials Coordinator
5 days ago
Beverly, Massachusetts, United States MDC Associates Full timeJob OverviewAs a Clinical Research Associate, you will act as a crucial intermediary between clinical trials and comprehensive clinical data. Your role will involve spearheading the identification, assessment, and establishment of clinical study sites for in-vitro diagnostic medical devices.This position offers a unique opportunity to significantly...
-
Branch Banking Client Consultant I
3 weeks ago
Beverly Hills, United States Flagstar Bank Full timePosition Title Branch Banking Client Consultant I Location Beverly Hills/17430 West 13 Mile Road/112070 Job Summary A Branch Banking Client Consultant I provides customers with high quality, prompt, and professional financial services. Responsible for interacting with clients and providing exceptional service by greeting them as they enter one of our...
-
Senior Vice President of Operations
6 days ago
Beverly, Massachusetts, United States Microline Surgical Inc. Full timePosition OverviewSUMMARY: The Senior Vice President of Operations is accountable for ensuring excellence in quality, timely delivery, safety, productivity, and the integration of continuous improvement methodologies, particularly Lean techniques, across all operational functions.KEY RESPONSIBILITIES: The individual in this role may be tasked with executing a...
-
Wealth Management Solutions Consultant
6 days ago
Beverly, Massachusetts, United States Bank of America Full timeJob Overview: At Bank of America, our mission is to enhance financial well-being through meaningful connections. We are committed to Responsible Growth, which guides our operations and ensures we serve our clients, colleagues, communities, and shareholders effectively. We strive to create a diverse and inclusive environment, welcoming individuals from...
-
Wealth Management Solutions Consultant
6 days ago
Beverly, Massachusetts, United States Bank of America Full timeJob Overview: At Bank of America, our mission is to enhance financial well-being through meaningful connections. We are committed to Responsible Growth, which guides our operations and our service to clients, colleagues, communities, and shareholders alike. We strive to create an inclusive and diverse workplace that values the unique backgrounds and...
-
Quality Assurance Specialist
6 days ago
Beverly Hills, California, United States Goddard Inc. Full timeJoin Our Team as a Quality Assurance SpecialistAs a vital member of our organization, you will contribute significantly to the assurance that our products are developed in alignment with industry standards, regulations, and engineering best practices.Your role will be essential in our expanding Quality Assurance and Verification & Validation team, ensuring...
-
Clinical Pharmacy Specialist
6 days ago
Beverly, Massachusetts, United States Walgreens Full timeJob Description:Job Summary:Delivers comprehensive clinical services to patients, including immunizations and medication therapy management (MTM) interventions, while ensuring adherence to regulatory standards and organizational policies.Key Responsibilities:Patient EngagementWelcomes patients with a friendly demeanor and provides assistance with various...
-
Clinical Pharmacy Specialist
6 days ago
Beverly, Massachusetts, United States Walgreens Full timeJob Description:Job Summary:Delivers comprehensive clinical services to patients, including immunizations and medication therapy management (MTM) interventions, while ensuring adherence to regulatory standards and company protocols.Key Responsibilities:Patient EngagementWelcomes patients with a friendly demeanor and provides assistance with products and...
-
Registered Dietician
1 week ago
Beverly, United States Marquis Health Services Full timeFull Time Registered Dietician Needed for a 132-bed Skilled Nursing Facility in the beautiful seaside town of Beverly!$5,000 Sign on Bonus!!Join a company that admires, cares, appreciates and values their employees! Join the team at Blueberry Hill as a member of our proud and caring staff. We care for our staff while we care for our residents and patients....
-
Registered Dietician
3 weeks ago
Beverly, United States Marquis Health Services Full timePart Time Registered Dietician Needed for a 132-bed Skilled Nursing Facility in the beautiful seaside town of Beverly!24 or 30 hours per weekFlexible schedule!$5,000 Sign on Bonus!!Join a company that admires, cares, appreciates and values their employees! Join the team at Blueberry Hill as a member of our proud and caring staff. We care for our staff while...
-
Registered Dietician
1 week ago
Beverly, United States Frontier Management (OR) Full timeFull Time Registered Dietician Needed for a 132-bed Skilled Nursing Facility in the beautiful seaside town of Beverly!$5,000 Sign on Bonus!!Join a company that admires, cares, appreciates and values their employees! Join the team at Blueberry Hill as a member of our proud and caring staff. We care for our staff while we care for our residents and patients....
Regulatory Affairs Consultant
2 months ago
As a Regulatory Affairs Consultnat you will lead regulatory projects and provide regulatory guidance IVD device manufacturers. You will be responsible for the overall planning of regulatory activities and in addition provide input on clinical study design and reports for our CRO services team. You will develop and implement strategies in a collaborative environment between colleagues and clients with the goal of successful regulatory submissions.
Responsibilities
- Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives
- Developing FDA Q-subs in collaboration with clients (Pre-subs, Breakthrough, STeP)
- Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies.
- Assist in the creation of Clinical and Analytical Study Protocols, Informed Consent Forms (ICFs), Study Database, and Data Collection Forms in conjunction with assigned Clinical Affairs Scientist and Project Managers.
- Assist client with product development process as needed.
- Development, compilation, review and submission of Regulatory Filings such as FDA 510(k), de novo and PMA submissions, Health Canada Licensure, EU Technical Files, etc.
- Interaction with regulatory agencies and Sponsors throughout the submission and review processes.
- Assist with business development, early client engagement, defining project scopes and supporting development of project proposals.
- Implementation of regulatory processes as they relate to company procedures, clinical studies, testing, and documentation and ensure that they are communicated through company policies and procedures.
Qualifications
- Bachelors degree in healthcare or other scientific discipline or educational equivalent.
- 5-10 years of IVD Regulatory Affairs experience with Clinical Trial Management as a plus.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines.
- Understanding of U.S. Food and Drug Administration (FDA) laws, regulations and guidances.
- Understanding of Health Canada Licensing Requirements and the EU IVDR. • Understanding of IRB guidelines and Common Rule.
- Knowledge of applicable protocol requirements as provided in company training.
- Computer skills including proficiency in use of Office 365, Microsoft Word, Excel, Access, Outlook and PowerPoint.
- Strong written and verbal communication skills including good command of English language.
- Excellent organizational, time management, and problem-solving skills.
- Attention to detail and accuracy in work.
- Ability to manage competing priorities without compromising quality.
- Effective mentoring and training skills with the ability to establish and maintain effective collaborative relationships with coworkers, managers and clients.
About MDC
For over 30 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
10-15% Travel including local, within U.S and outside of the US. Travel may include:
- Attending OneMDC (twice annual company retreat)
- Attending off-site client meetings
- Attending FDA Meetings (i.e: Pre-Submission Meeting, Submission Issue Meetings, etc.)
- Attending industry conferences (e.g. ADLM, AMDM, RAPs, etc.)
Pay & Benefits:
- Salary + Bonus
- Equity Plan
- Medical, Dental, and Vision Insurance
- Flexible Spending / Dependent Care Accounts
- STD/LTD/GTL/VTL
- 401(k) w/ match potential
- Generous PTO / Sick time policy
Powered by JazzHR
SjUij5vRmS