Senior Regulatory Affairs Specialist

2 weeks ago

Norristown, Pennsylvania, United States Globus Medical Full time
About Us

:


At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders.

Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them.

We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions.

Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary

:


Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.

Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.
Essential Functions

:

Determines the appropriate regulatory strategy for new products and documents all related activates to remain in compliance
Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
Collaborates with various departments to review the required plans, procedures and regulatory decisions for new or existing products
Reviews regulatory requirements from other departments for new product designs or changes to existing designs
Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances
Supports product import by providing applicable regulatory documentation and certificates

Performs other duties as assigned Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.

Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these

essential

functions.
Qualifications

:

Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience
5+ years of related experience in the medical device industry
Understanding of regulatory requirements throughout the product lifecycle
Solid understanding of regulatory terminology, pre-market submission types, and requirements
Able to evaluate regulatory impact of proposed product and process changes
Capable multi-tasking skills with the ability to project plan and meet deadlines
Result driven with a sense of responsibility, urgency and ability to perform under pressure
Our Values

:

Our Life Moves Us philosophy is built on four values:

Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation :

Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions
Customer Focused :

We listen to our customers' needs and respond with a sense of urgency
Teamwork :

Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger
Driven :

We pursue our mission with energy and passion. We are nimble, results-oriented and decisive.

We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Physical Demands

:


The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including:

close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Equal Employment Opportunity

:

Globus Medical is an equal opportunity employer.

All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship.

We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.
Other Duties

:


Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

#J-18808-Ljbffr

  • Senior Analyst, Corporate Development

    2 weeks ago

    Norristown, Pennsylvania, United States Globus Medical Full time

    About Us :At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and...

  • Regulatory Specialist

    7 days ago

    Norristown, United States Globus Medical Full time

    The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/ PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FD Regulatory, Specialist, Clinical, Regulatory Affairs, Product Development, Healthcare

  • Lead Regulatory Affairs Specialist

    1 month ago

    Norristown, United States Globus Medical Full time

    About Us: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and...

  • Senior Regulatory Specialist

    2 days ago

    Norristown, United States Minster Bank Full time

    At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them. Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that...

  • Regulatory Specialist

    2 weeks ago

    Norristown, United States Globus Medical Full time

    At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them. Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that...

  • Senior Sales Trainer, Orthopedics Division

    1 month ago

    Norristown, United States Globus Medical Full time

    About Us: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and...

  • Senior Analyst, Corporate Development

    2 weeks ago

    Norristown, United States Globus Medical Full time

    About Us: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and...

  • Senior Project Engineer

    4 weeks ago

    Norristown, United States Total Engineering & Consulting Services LLC Full time

    Job DescriptionJob DescriptionBenefits:401(k)401(k) matchingBonus based on performanceCompany partiesCompetitive salaryDental insuranceFlexible scheduleHealth insuranceOpportunity for advancementPaid time offTraining & developmentTuition assistanceVision insurance Total Engineering & Consulting Services, LLC (TEC) is seeking an experienced Project or Senior...

  • Sr. Market Design Specialist I

    1 month ago

    Norristown, United States PJM Inc Full time

    Flexible Work Arrangement: HybridThis position is seeking a talented and motivated Market Design Specialist to join our dynamic team. The Market Design Specialist will work directly with the Manager of market design in support of significant market design enhancements across all PJM's markets and will be responsible for designing, analyzing and optimizing...

  • Sr. Market Design Specialist I

    1 month ago

    Norristown, United States PJM Inc Full time

    Flexible Work Arrangement: Hybrid This position is seeking a talented and motivated Market Design Specialist to join our dynamic team. The Market Design Specialist will work directly with the Manager of market design in support of significant market design enhancements across all PJM's markets and will be responsible for designing, analyzing and optimizing...

  • Senior Director, Data Product Management

    3 weeks ago

    Norristown, United States MRO Full time

    The Senior Director, Data Product Management will play a critical role in shaping MRO's growth trajectory as a leader in clinical data exchange.The Senior Director will collaborate with cross-functional teams to unlock the power of the vast amounts of data that MRO exchanges across the healthcare ecosystem. The Senior Director will lead new product...

  • Senior Electro-Mechanical Engineer

    4 weeks ago

    Norristown, United States TriMech Services Full time

    Job DescriptionJob DescriptionSenior Electro-Mechanical EngineerJob Description:Design mechanical structures, supports, BUS work, electrical controls, metering and communications to meet customer requirements.Create parts lists, metal drawings, BUS drawings, assembly drawings, BOM as well as Operation & Maintenance Manual in a timely and efficient...

  • Environmental Health Specialist

    4 weeks ago

    Norristown, United States Montgomery County Pennsylvania Full time

    SUMMARY When applying for this position, kindly make certain to attach/upload a resume. An Environmental Health Specialist will provide inspections, enforcement services, and education for a broad range of environmental health programs to ensure compliance and uniformity under the Montgomery County Public Health Code and other statutes, regulations and...

  • Data Entry Specialist

    3 days ago

    Norristown, United States Software Galaxy Systems Full time

    Job Summary:Assists with the development, implementation, and monitoring procedures for data collection, data entry, reporting, records management, and other data management and quality improvement activities for five (5) service areas (departments) within the Early Head Start Program, serving approximately 300 people, including expectant families, infants,...

  • Senior Therapeutic Area Specialist, Neuro Psych

    4 weeks ago

    Norristown, United States Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Contractor Attorney

    1 month ago

    Norristown, United States PJM Interconnection Full time

    THIS POSITION IS HYBRID - This position is a Contractor positionExperienced Federal Energy Regulatory Commission ("FERC") Contract Attorney responsible for supporting PJM's Mission and Vision in the areas of operations, planning, markets, commercial and compliance. Working closely with senior lawyers in the department, the Contract Attorney will develop,...

  • Vice President of Underwriting | Commercial Line Middle Market Team

    1 month ago

    Norristown, United States IAT Insurance Group Full time

    IAT Insurance Group is currently seeking a Vice President of Underwriting for the Middle Market Excess Casualty team. This position involves supervising a regional team of underwriters in the Excess Casualty Middle Market underwriting division. The VP will assist in establishing underwriting policies and standards, work with senior management to develop and...

  • Mobile Therapist

    1 week ago

    Norristown, United States Public Health Management Full time

    PHMC is proud to be a leader in public health. PHMC requires all employees to be fully vaccinated for COVID-19 before the first day of employment. We will offer the vaccination at no cost via our Health Centers. SUBSIDIARY: Carson Valley Children's Aid PROGRAM: Intensive Behavioral Health Services (IBHS) - Montgomery County & Delaware County ROLE TYPE:...

  • Mobile Therapist

    2 weeks ago

    Norristown, United States PHMC Full time

    PHMC is proud to be a leader in public health. PHMC requires all employees to be fully vaccinated for COVID-19 before the first day of employment. We will offer the vaccination at no cost via our Health Centers. SUBSIDIARY: Carson Valley Children's Aid PROGRAM: Intensive Behavioral Health Services (IBHS) - Montgomery County & Delaware County ROLE TYPE:...

  • Manager-Compliance

    3 weeks ago

    Norristown, United States FUJITSU FRONTECH NORTH AMERICA INC Full time

    Job DescriptionJob DescriptionSummaryThis position is responsible for the management, oversight, and development of compliance policies/processes/results for Fujitsu Frontech North America Inc. (FFNA). The Manager - Compliance will drive compliance across multiple channels. Ensures that the activities of the company are in compliance with...

  • Pharmacy Technician

    1 month ago

    Norristown, United States CVS Health Full time

    Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we...