Regulatory Affairs Specialist
6 months ago
**Location: Remote, Remote**:
**Circulation**:
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
**Job Summary**
The Senior Regulatory Affairs Specialist is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.
**Essential Functions**
- Support in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
- Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
- Work with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups.
- Work with department management provides global regulatory strategies and regulatory plans.
- Work with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities.
- Coordinate/prepare and maintain FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements.
- Coordinate/prepare and maintain CE files in accordance with current Medical Device Directive requirements, manages Essential Requirement checklists and ensures timely updates for all applicable CE certifications.
- Coordinate and prepare responses to FDA/NB or other such regulatory agency letters.
- Support Reviews of product labeling changes.
- Review promotional literature and marketing materials.
- Support CAPA and CAPA closure.
- Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company
- Participate in regulatory audits/inspections as required.
- Write SOPs and train key personnel as needed.
**Required/Preferred Education and Experience**
- Bachelor's Degree required
- 6+ years of regulatory experience in the Medical Device Industry required and
- Experience with medical device regulatory submissions (510(k) or PMA) required and
- Previous experience working with Regulatory Authorities relative to premarket and compliance activities. required and
- Experience with medical device submissions required
**Knowledge, Skills and Abilities**
- Project management skills
- Degree in RA or Regulatory Affairs Certification a plus
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to work with mínimal supervision, recognize departmental needs and initiate/recommend actions for resolution
- Knowledge of U.S. and European/International regulations and standards
- Experience interacting with FDA and/or other regulatory agencies
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Documented evidence of writing skills
- Familiarity with medical terminology a plus
**Travel Requirements**
- 10% travel required
**Physical Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
-
Regulatory Affairs Specialist
6 months ago
Kuala Lumpur, Malaysia Zoll Medical Corporation Full time**Regulatory Affairs Specialist**: **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients...
-
Specialist, Regulatory Affairs
6 months ago
Kuala Lumpur, Malaysia Organon Full time**Responsibilities**: The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting...
-
Kuala Lumpur, Kuala Lumpur, Malaysia Agensi Pekerjaan Great Pyramid Sdn Bhd Full timeAt Agensi Pekerjaan Great Pyramid Sdn Bhd, we are seeking a highly skilled Risk Management and Regulatory Affairs Specialist to join our team.About the RoleThe successful candidate will be responsible for providing strategic risk management and regulatory affairs expertise to support the company's growth and expansion. This role is crucial in ensuring that...
-
Executive, Regulatory Affairs
8 months ago
Kuala Lumpur, Malaysia DKSH Full time**Location**:Kuala Lumpur, MY, MY**Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations **General Responsibilities** - Support superior in managing day-to-day operating...
-
Regulatory Affairs Specialist
3 months ago
Kuala Lumpur, Malaysia Novonesis Full time**Location**: Malaysia : Kuala Lumpur **Country**: Malaysia**Our purpose points the way** In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world...
-
Regulatory Affairs Manager
7 months ago
Kuala Lumpur, Malaysia BI (Malaysia) Sdn. Bhd Full time**The Position**: - To achieve timely & successful product registrations in accordance with corporate & local strategies. - To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products. - To ensure compliance with Company...
-
Regulatory Affair Executive/manager
6 months ago
Kuala Lumpur, Malaysia NuFarm Full timeRegulatory Affair Executive/ Manager Support Registration of Few Countries in SOUTHEAST Asia Grow a Better Tomorrow with Nufarm. Nufarm is the dependable partner behind thousands of agricultural success stories. Every day, growers around the world turn to our products and our people to help with the challenges of fighting disease, weeds, and pests, and...
-
Regulatory Affairs Specialist
6 months ago
Kuala Lumpur, Malaysia BD Full time**Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...
-
Regulatory Affairs Specialist
7 months ago
Kuala Lumpur, Malaysia BD Full time**Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...
-
Quality Assurance
6 months ago
Kuala Lumpur, Malaysia Recruit Express Full time**Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...
-
Junior Regulatory Affairs, Quality Assurance
6 months ago
Kuala Lumpur, Malaysia Agensi Pekerjaan Permit Pro Consultancy Sdn Bhd Full time**Job Summary**: As a Junior Regulatory Affairs, Quality Assurance & Compliance Executive, you will play a crucial role in supporting regulatory processes, ensuring compliance, and maintaining product quality within the specified regions of Malaysia, Philippines, Vietnam, Singapore, Cambodia, Laos, and Myanmar. This role involves assisting with product...
-
Regulatory Affairs Specialist
7 months ago
Kuala Lumpur, Malaysia BD Full timeWe are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the...
-
Protégé - Regulatory Affairs
8 months ago
Kuala Lumpur, Malaysia Pfizer Full timeThe Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to Regulatory Authority and other administrative tasks. - Administrative Duties: Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photostating, store maintenance, dispatch...
-
Regulatory Affairs Executive
6 months ago
Kuala Lumpur, Malaysia The Estée Lauder Companies Full timeThe Regulatory Affairs Executive is responsible for ensuring that our products meet all legislative requirements. Key duties of the job include studying scientific and legal documents, gathering, evaluating, organising, managing and collating information in a variety of formats. **What You Will Achieve** - **Ensures Compliance**:Ensures all products meet...
-
Regulatory Affairs Associate, Malaysia
6 months ago
Kuala Lumpur, Malaysia iNova Pharmaceuticals Full time**iNova was certified as a Best Place to Work in 2021. We are innovative, motivated, and passionately solution focused to support our customers in leading a healthy lifestyle. Join the team to experience the reasons why people love working for us!** **The Opportunity** We currently have an opportunity for an experienced Regulatory Affairs Associate,...
-
Quality Assurance
6 months ago
Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time**Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...
-
Public Affairs Specialist
6 months ago
Kuala Lumpur, Malaysia Danau Sentral Sdn. Bhd. Full time**Responsibilities**: - Review, monitor, and analyze legislative and regulatory issues and trends within the country. - Develop and execute advocacy campaigns aimed at shaping public policy and regulations. - Facilitate policy, regulatory, and crisis management. - Collaborate with government agencies, industry associations, and other stakeholders to...
-
Quality Assurance and Regulatory Affairs Executive
6 months ago
Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time**Key Responsibilities** - Implement quality assurance policies and procedures to ensure compliance with applicable regulations and standards. - Support all aspects of the Quality Management System including updating QMS manuals, SOPs and forms, conducting internal audits, and follow-ups on NC/CAPA. - Investigate and resolve quality issues, including...
-
Specialist, Regulatory Affairs
6 months ago
Kuala Lumpur, Malaysia Organon Full time**Responsibilities**: The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting...
-
Lead Specialist
7 months ago
Kuala Lumpur, Malaysia Baker Hughes Full time**Be part of a successful team** As an energy technology company with a portfolio of low-carbon solutions across the energy value chain, Baker Hughes’ purpose is to take energy forward - making it safer, cleaner, and more efficient for people and the planet. We are thought leaders in the future of energy, responsible for delivering our corporate emission...