- Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams with the role of defining regulatory requirements, approval timelines etc. for international submissions.
- Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities and/or distributors ( SFDA, and other GCC regulatory authorities).
- Interacts with various levels of management, external agencies and companies.
- Develops, maintains and analyzes department systems and provides training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Assists with facility inspections, Notified Body Audits and other governmental inspections as directed.
- Contributes to continuous improvement initiatives.
- Assists with supervision of department staff, as directed.
- Performs other related duties and tasks, as required.
- Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and six years of related experience.
- Demonstrated knowledge of global regulatory requirements with particular emphasis on GCC medical device regulations, notably SFDA.
- Have a good understanding of FDA regulations, EU regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc
- Supervisory skills are preferred.
- Demonstrated computer skills preferably spread sheets, word processing, database, internet research and other applicable software programs.
- International Regulatory requirements
- Regulatory submission/rationale preparation
- Medical device and vigilance reporting
- Computer skills/internet research
- Interpersonal/communication skills
- Regulatory system development/training
- Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
- Self-motivated, self-directing
- Strong attention to detail and excellent time management skills
- Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
- Language skills: advanced English.
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Senior Regulatory Affairs Specialist - Maastricht, Nederland - Merit Medical Systems Inc
Beschrijving
Job Description
SUMMARY OF DUTIES
This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level, for Saudi Arabia and GCC region. Primary responsibilities are to ensure regulatory compliance for assigned countries as Merit evolves. Other responsibilities include product life cycle management in accordance with regional requirements, supporting vigilance and recalls, identifying relevant standards and guidance documents that affect Merit's business and products, assisting with facility inspections, Notified Body audits and other Regulator audits, conducting internal audits when directed and making recommendations as appropriate. This position will be based in Saudi Arabia.
ESSENTIAL FUNCTIONS PERFORMED
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
As recommended by Occupational Physician at pre-employment medical.
SUMMARY OF MINIMUM QUALIFICATIONS
COMPETENCIES
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
Merit Medical Systems, Inc. , an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at to see the video titled "Great people, Great products, Great Company". Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V
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Gebruikers van het beroep Senior Regulatory Affairs Specialist in Maastricht
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