Regulatory Affairs Specialist - Westborough, United States - CERES Group

CERES Group Westborough, United States

2 weeks ago

Description

Regulatory Affairs Specialist

Location:
Marlborough, Massachusetts

Do you have a proven track record of working with Regulations and the implementation of labeling for Medical Device UDI project? Do you want to work on a fantastic team as they undergo the changes for the EU MDR? If so, this is the job for you.

Responsibilities:

Responsible for the development of corporate SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR and IVDR.
Ensures all corporate procedures impacted by the new procedures are identified, assessed for updates, changes needed and that these changes are completed as appropriate.
Develops training material and provides training to divisional SMEs (Subject Matter Experts) to support the effective implementation of the new process.
Develops and maintain a quality plan to define all key milestones needed to develop the procedures, system changes, validation etc. to maintain the integrity of the Corporate Quality Systems during the implementation of these new processes.
Develops and maintains a detailed project plan if needed to support these activities.
Provides periodic updates on progress, accomplishments, risks and mitigation plans related to the new processes.
Maintains periodic and effective communication with the divisional and corporate teams involved in the development of the new processes.
Works with the Information Services (IS) team to identify systems changes needed to support the new requirements.
Ensures all requirements are clearly communicated to the divisions proactively.
Ensure all activities are completed on time according to established dates.

Qualifications:
Bachelor's degree (BA) Scientific, Regulatory or Graphics Design - Required U.S. Bachelor's Degree (4-year university degree) or ex-U.S. equivalent. Degree or background in life sciences, technical (engineering) or related field.

Project Management experience. PMP Certification is a bonus.
Have 8+ years prior RA experience.
Minimum five years direct experience in an FDA or EU Regulated environment a must, preferably with respect to the release of labeling and UDI.
Experience with translation activities desirable
Experience with EU MDR/IVDR a bonus
Regulatory Affairs Certification(s) (U.S., EU or Global) desirable.
The incumbent's regulatory background should include the medical device and IVD.
A combination of education and experience may be considered.
Demonstrated strong oral and written communication skills; ability to communicate effectively at multiple levels.
Current knowledge of relevant US and International Regulations (including but not limited to); FDA QSR (21CFR 820,), ISO Requirements, GMP, IVDD (Directive 98/79/EC), MDD (Directive 93/42/EEC) MDR (Regulation (EU) 2017/745), IVDR (Regulation (EU) 2017/746) requirements) and ability stay abreast of regulations pertinent to medical devices, IVDs, and combination products.
Practical knowledge of Project Management including experience managing complex projects with cross-functional teams.
Knowledge of labeling workflow from creation to obsolescence.
Strong attention to details, and ability to multitask and prioritize tasks.
Ability to read, interpret and stay abreast of global regulations pertinent to medical devices, IVD products.
Drives change, challenges the status quo and makes recommendations for improvements to processes.
Creates tools that help simplify job tasks and shares these with others.
Prior experience in team management within a matrix organization desirable.
Foster successful teamwork and morale during stressful situations.

Skills:
SOP, FDA, Regulatory Affairs Operations, GMP (Good Manufacturing Practice)
#LI-JW1

#J-18808-Ljbffr

Principal Regulatory Affairs Specialist

1 week ago

Boston Scientific Corporation Marlborough, United States

**Work mode**:Hybrid**Onsite Location(s)**:Marlborough, MA, US, 01752**Recruiter**: Spencer Gregory Hale**Principal Regulatory Affairs Specialist** · **About the role**: · - Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to ...
Public Affairs Specialist

2 days ago

U.S. Department of Justice Boston, United States

Summary · This job is open to · Career transition (CTAP, ICTAP, RPL) · Federal employees who meet the definition of a "surplus" or "displaced" employee. · Family of overseas employees · Family members of a federal employee or uniformed service member who is or was, working overse ...
Research Affairs Specialist

1 week ago

Tufts University Boston, United States

Overview: · Dental Research Administration (DRA) at TUSDM is the main research structure for all basic science and clinical projects at the Dental School. DRA is the liaison to the Office of the Vice Provost, Sponsored Accounting, IRB, IACUC, DLAM, Biosafety and all other offices ...
Principal Regulatory Affairs Specialist

2 weeks ago

Philips Cambridge, United States

**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
Sr. Regulatory Affairs Specialist

1 week ago

Boston Scientific Marlborough, MA, United States

Recruiter: Spencer Gregory Hale · Sr. Regulatory Affairs Specialist - Endoscopy · About the role: · Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagno ...
Sr. Regulatory Affairs Specialist

5 days ago

Boston Scientific Gruppe Marlborough, United States

Press Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Create Alert · Select how often (in days) to receive an alert: · Sr. Regulatory Affairs Specialist - Endoscopy · Onsite Location(s): · Marlborough, MA, US, 01752 · Recruiter: · Spen ...
Sr. Regulatory Affairs Specialist

2 weeks ago

Knewin Marlborough, United States

Recruiter: · Spencer Gregory Hale · Sr. Regulatory Affairs Specialist – Endoscopy · About the role: · Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for dia ...
Sr. Regulatory Affairs Specialist

3 weeks ago

Boston Scientific Marlborough, United States

Recruiter: Spencer Gregory Hale · Sr. Regulatory Affairs Specialist - Endoscopy · About the role: · Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for dia ...
Principal Regulatory Affairs Specialist

6 days ago

Boston Scientific Marlborough, United States

Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S 4 HANA. Magellans goal is to simplify, standardize and modernize our core business processes, enabling BSC to better leverage the power of d Regulatory Affairs, Regulatory ...
Principal Regulatory Affairs Specialist

4 days ago

Boston Scientific Marlborough, United States

Recruiter: · Spencer Gregory Hale · Principal Regulatory Affairs Specialist · About the role: · Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan's goal is to simplify, standardize and modernize our core ...
Principal Regulatory Affairs Specialist

1 week ago

Boston Scientific Marlborough, United States

Recruiter: Spencer Gregory Hale · Principal Regulatory Affairs Specialist · About the role: · Magellan is a global business transformation program accompanying a move of our ERP system from SAP ECC to S4 HANA. Magellan's goal is to simplify, standardize and modernize our core ...
Regulatory Affairs Specialist

3 weeks ago

Randstad North America, Inc. Cambridge, United States

As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs, Specialis ...
regulatory affairs specialist

1 week ago

Randstad Cambridge, United States

regulatory affairs specialist (cambridge). · cambridge , massachusetts · posted 3 days ago · job details · summary · $65 - $80 per hour · contract · bachelor degree · category computer and mathematical occupations · reference · job details · job summary · Your Respons ...
Regulatory affairs specialist

2 weeks ago

Randstad Cambridge, United States

job summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...
Regulatory Affairs Specialist

3 days ago

Philips Cambridge, United States Full time

JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
Regulatory Affairs Specialist

3 weeks ago

Philips Cambridge, United States Full time

Job Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
Scientific Affairs Specialist

1 week ago

Bruker Billerica, United States

· Scientific Affairs Specialist · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Research & Development · Overview · As one of the world's leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields ...
Scientific Affairs Specialist

1 week ago

Bruker Billerica, United States

Scientific Affairs Specialist · Job Locations · US-MA-Billerica · ID · # of Openings · 1 · Job Function · Research & Development · Overview · As one of the world's leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all f ...
Regulatory Affairs Specialist

1 week ago

Philips Cambridge, United States Full time

JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
Medical Affairs Specialist

1 week ago

Philips Cambridge, United States Full time

Job Title · Medical Affairs SpecialistJob Description · As a Medical Affairs Specialist, you will help to develop the Medical Office within HPM, contribute with clinical context in the whole lifecycle of our solutions and products. In close contact with selected customers and adv ...