- 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.
- 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.
- 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.)
- 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
-
Regulatory Affairs Consultant
1 week ago
MDC Associates LLC Beverly, United StatesAs 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 ...
-
Regulatory Affairs Consultant
3 weeks ago
MDC Associates Beverly, United StatesJob Description · Job 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 stud ...
-
Regulatory Affairs Consultant
3 weeks ago
MDC Associates LLC Beverly, United StatesAs 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 ...
-
Senior Regulatory Affairs Consultant
1 week ago
PAREXEL Billerica, United StatesBring your regulatory expertise and passion for combination products to ParexelExcellent opportunity for a "cradle to crypt" Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologiesParexel's incredible Regulatory Consultin ...
-
Consultant, Regulatory Affairs
3 weeks ago
Halloran Consulting Group Boston, United StatesAre you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran's Regulatory team in the Consultant, Regulatory Affairs role today · In this role, you will partner with client companies ...
-
Lead Clinical Data Manager
3 weeks ago
MDC Associates Beverly, United StatesJob Description · Job DescriptionAs a Lead Clinical Data Manager you will lead the development, implementation, and management of databases used in support of US FDA and ex-US Regulatory submissions of in vitro diagnostic devices. This new role will also oversee the data manageme ...
-
Clinical Scientist
3 weeks ago
MDC Associates Beverly, United StatesJob Description · Job DescriptionAs a Clinical Scientist, you will champion clinical study design and collaborate with study partners and IVD manufacturers to support successful regulatory submissions. You'll develop clinical study protocols, take the lead on clinical and method ...
-
Destination Salem Hiring Executive Director
1 week ago
Talentuition, LLC Salem, United StatesJob Description · The Opportunity · The Salem Office of Tourism and Cultural Affairs (dba Destination Salem) is seeking a strategic, collaborative, energetic, and experienced leader to serve as the organization's next Executive Director. · About Destination Salem · Destinatio ...
-
Lead Clinical Data Manager
2 weeks ago
MDC Associates LLC Beverly, United StatesAs a Lead Clinical Data Manager you will lead the development, implementation, and management of databases used in support of US FDA and ex-US Regulatory submissions of in vitro diagnostic devices. This new role will also oversee the data management team and be responsible for th ...
-
Clinical Research Associate
3 weeks ago
MDC Associates Beverly, United StatesJob Description · Job 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 hav ...
-
Registered Nurse: Clinical Assessment and
3 weeks ago
AgeSpan Danvers, United States**AgeSpan** · - Formerly Elder Services of the Merrimack Valley/North Shore_ · **About Us**:Since 1974 our agency has strived towards supporting an individual's desire to make their own decisions, secure their independence and remain living independently in the community. We are ...
-
Material tester or physics laboratory assistant
2 weeks ago
Terra Nova Group Peabody, MA, United States Freelance**Department 9.5 - Tribology and Wear Protection · We are looking for a *Material Tester* or *Physics Laboratory Technician* (m/f/d) to strengthen our team in the department "Tribology and Wear Protection" in Berlin-Steglitz at the earliest possible date.** · Pay grade 6 TVöD · P ...
-
Gordon Conwell Theologi South Hamilton, United StatesJob Description · Job DescriptionOverview · Gordon-Conwell is a multidenominational, Protestant graduate school, unique with its broad array of over 2100 students and 200 faculty and staff from 98 denominations and over 64 countries. We offer a residential model of education at ...
-
Assistant Dean, Student Conduct
11 hours ago
Boston College Newton, United StatesFounded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,484 full-time undergraduates and 5,250 graduate and professional students. Ranked 35 among national universities, Boston College has 888 full-time and 1 ...
-
Clinical Dietitian Unregister
2 days ago
Newton-Wellesley Hospital(NWH) Newton, United StatesEnsure that quality nutritional care is provided to patients in a timely manner according to established screening and assessment standards. Develop and implement individualized, interdisciplinary nutrition care plans based on a patient's nutritional status and patient/family edu ...
-
Government Affairs Manager
3 days ago
Stericycle Inc. Bannockburn, United StatesTitle: Government Affairs Manager · Requisition Id: 32142 · Job Function: Legal · Career Area: Corporate Jobs · Work Location: Bannockburn CORP) · About Us: · At Stericycle, we deliver solutions and drive innovations that protect the environment, people, and public health. This i ...
-
Veeva Systems Boston, United States Full timeThe Role · We are seeking talented individuals to join the Veeva Business Consulting group in Medical, a priority area for Veeva. We work with senior customer stakeholders, as the digital partner of choice for 85% of the top 20 Pharmaceutical companies, to define and realize the ...
-
Director Medical Affairs Psychiatry
3 days ago
Lundbeck Deerfield, United StatesDirector Medical Affairs Psychiatry - Remote Opportunity · Requisition ID: 5094 · Location: · Deerfield, Illinois, US · Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we ...
-
Interactions Specialist
1 week ago
Stefanini, Inc Deerfield, United StatesJob Description · Job DescriptionReference #57277 · Stefanini Group is hiring · Stefanini is looking for Interactions Specialist · - Part Time (Remote) · For quick Apply, please reach out to Mohit Basson · - call: / email: · Work Hours: M · -F (20 hours) · Work Location: Remot ...
-
SENIOR CONSULTANT, Continuous Improvement
1 week ago
Boston University Boston, United States Full time/RegularSENIOR CONSULTANT, Continuous Improvement & Data Analytics · Tracking Code Job Description The Senior Consultant within Continuous Improvement & Data Analytics (CIDA) is a member of the Continuous Improvement (CI) internal consulting team that supports Boston University leadersh ...
Regulatory Affairs Consultant - Beverly, United States - MDC Associates LLC
3 weeks ago
Description
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
Qualifications
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
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:
Pay & Benefits:
Powered by JazzHR
