Specialist I, Regulatory Affairs - Medical Device
Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.
The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.
We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.
Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.
Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position
Summary:
The Specialist I, Regulatory Affairs (RASI) assists with the execution of pre and/or post market regulatory affairs departmental functions as assigned by management.
The RASI premarket role includes, but is not limited to, assisting in the preparation of documentation and information required to place and to keep products on the market:
global regulatory submissions, licensing, and registrations.
Establishment related registration activities are included.
The RASI post market role includes, but is not limited to, assisting in the execution of post market surveillance activities:
complaint evaluation, medical device reporting, vigilance reporting, product correction, removals, and recalls.
In addition, this role supports regulatory internal audits, 3rd party audits/inspections, technical files, dossiers, product labeling, regulatory training, standards and regulation tracking, translations, and regulatory legal.
Key Accountabilities
Essential Functions:
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in efforts to ensure the company is properly registered and in compliance with applicable federal, state, local and international regulations (ex.
Food and Drug Administration (FDA) for which Regulatory Affairs (RA) is responsible.
Assist in efforts to prepare and submit regulatory submittals for market clearance, licensing, registration and legalization.
Assist in executing regulatory compliance programs; coordinate required training.
Assist in tracking standards, regulations and all applicable requirements.
Assist in executing global field corrective actions/recalls.
Assist in executing timely and effective global reporting of medical devices malfunctions and adverse events.
Assist in conducting final Level 1 case reviews prior to complaint closure.
Assist in authoring trending reports for pre- and post-market regulatory activities.
Assist cross functional teams in timely and effective closure of RA corrective and preventive actions (CAPAs).
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Accurately and completely document regulatory and quality activities as required.
Develop increasing working knowledge of regulations, standards, company SOPs and tools.
Other duties as assigned.
Minimum Knowledge & Experience Required for the Position:
Bachelors degree (Science preferred) or equivalent applicable experience.
Minimum of one (1) to two (2) years in Regulatory Affair or combination experience in regulatory affairs, clinical affairs, and quality assurance RASI.
Must possess demonstrated experience working in an FDA regulated environment such as medical device or pharmaceutical.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Must possess awareness of the requirements of relevant federal and international regulations such as those issued by the Food and Drug Administration (FDA) as the Quality System Regulations (QSR) and applicable standards issued by the International Standards Organization (ISO).
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Good written and verbal communication skills.
Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team.
Strong computer skills required:
MS Office, ability to use an enterprise resource planning system (ERP) and other regulatory software tools.
The annual base salary range for this role is $75,000 to $85,000.
Final compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and business needs.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity.
We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
We operate directly in over 30 countries, and in more than 100 territories through distributors.
Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.
werfen.
com Job ID:
2023-6536 Shift:
1st External Company URL:
https:
//werfen.
com/en Street:
6260 Sequence Drive Recommended Skills Auditing Business Requirements Clinical Works Communication Medical Device Reporting Medical Material Estimated Salary: $20 to $28 per hour based on qualifications.
The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.
We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.
Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.
Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position
Summary:
The Specialist I, Regulatory Affairs (RASI) assists with the execution of pre and/or post market regulatory affairs departmental functions as assigned by management.
The RASI premarket role includes, but is not limited to, assisting in the preparation of documentation and information required to place and to keep products on the market:
global regulatory submissions, licensing, and registrations.
Establishment related registration activities are included.
The RASI post market role includes, but is not limited to, assisting in the execution of post market surveillance activities:
complaint evaluation, medical device reporting, vigilance reporting, product correction, removals, and recalls.
In addition, this role supports regulatory internal audits, 3rd party audits/inspections, technical files, dossiers, product labeling, regulatory training, standards and regulation tracking, translations, and regulatory legal.
Key Accountabilities
Essential Functions:
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in efforts to ensure the company is properly registered and in compliance with applicable federal, state, local and international regulations (ex.
Food and Drug Administration (FDA) for which Regulatory Affairs (RA) is responsible.
Assist in efforts to prepare and submit regulatory submittals for market clearance, licensing, registration and legalization.
Assist in executing regulatory compliance programs; coordinate required training.
Assist in tracking standards, regulations and all applicable requirements.
Assist in executing global field corrective actions/recalls.
Assist in executing timely and effective global reporting of medical devices malfunctions and adverse events.
Assist in conducting final Level 1 case reviews prior to complaint closure.
Assist in authoring trending reports for pre- and post-market regulatory activities.
Assist cross functional teams in timely and effective closure of RA corrective and preventive actions (CAPAs).
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Accurately and completely document regulatory and quality activities as required.
Develop increasing working knowledge of regulations, standards, company SOPs and tools.
Other duties as assigned.
Minimum Knowledge & Experience Required for the Position:
Bachelors degree (Science preferred) or equivalent applicable experience.
Minimum of one (1) to two (2) years in Regulatory Affair or combination experience in regulatory affairs, clinical affairs, and quality assurance RASI.
Must possess demonstrated experience working in an FDA regulated environment such as medical device or pharmaceutical.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Must possess awareness of the requirements of relevant federal and international regulations such as those issued by the Food and Drug Administration (FDA) as the Quality System Regulations (QSR) and applicable standards issued by the International Standards Organization (ISO).
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Good written and verbal communication skills.
Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team.
Strong computer skills required:
MS Office, ability to use an enterprise resource planning system (ERP) and other regulatory software tools.
The annual base salary range for this role is $75,000 to $85,000.
Final compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and business needs.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity.
We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
We operate directly in over 30 countries, and in more than 100 territories through distributors.
Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.
werfen.
com Job ID:
2023-6536 Shift:
1st External Company URL:
https:
//werfen.
com/en Street:
6260 Sequence Drive Recommended Skills Auditing Business Requirements Clinical Works Communication Medical Device Reporting Medical Material Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
