Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Audubon, Pennsylvania
INTERNATIONAL REGULATORY SPECIALIST
Globus Medical is looking for a talented and experienced International Regulatory Affairs Specialist to support international product registration and development at our Globus Medical headquarters located in Audubon, Pennsylvania.
The International Regulatory Affairs Specialist is responsible for implementation of regulatory strategies and to write, submit and gain approval of product registrations and other submissions to international Regulatory agencies.
This position entails development of submissions in conjunction with other Globus departments, requiring working knowledge of products under review, maintaining an excellent understanding of global medical device regulations such in Europe, Japan, Latin America, other geographies and other relevant regulations, international standards and guidance documents.
The International Regulatory Affairs Specialist is an enthusiastic, positive, even-tempered and effective in building working relationships with development teams. Experience should demonstrate dependability, flexibility and maturity. Occasional travel may be required.
* Work with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files and design dossiers, and other international filings, to obtain and maintain market access.
* Obtain timely market access for products in parallel with US submissions.
* Submit documents and timely responses with international Regulatory bodies, in accordance with local and international regulations.
* Provide Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations.
* Coordination, review, and submission of product labeling for marketing outside the United States.
* Routine maintenance of approved files, including coordination and preparation of amendments as necessary.
* Review design changes and technical files for updates to documentation.
* Develop relevant Regulatory procedures and work instructions as necessary.
* File Certificates to Foreign Governments with FDA.
* Ensure conformance to ISO, CE, FDA and other international/local regulations.
* Understand spinal surgical techniques and the use of spinal implant and instrument systems.
* Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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.
* Represent 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 of Globus.
Qualification: Education - Experience
* BS degree in health or science-related field. Engineering degree is a plus.
* Minimum of 4 years experience in the medical device industry.
* Minimum of 2 years experience in International Regulatory Affairs in medical device industry. Experience with spinal devices is a plus. Ideally have knowledge of requirements in accordance with MDD 93/42/EEC, Japanese, Latin America and other relevant regulations, International standards (ISO 13485) and guidance documents (MEDDEVs).
Qualifications: Knowledge, Skills and Abilities Required
* Able to maintain confidentiality in dealing with regulatory and clinical documentation.
* Self-starter with excellent organizational, planning, and follow-up skills.
* Strong attention to detail.
* Willingness to learn and a positive attitude.
* Ability to work independently.
* Able to prioritize and handle several projects concurrently and to meet strict deadlines.
* Excellent verbal, written and organizational skills.
* Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization.
* Good communication and interpersonal skills.
* Proven problem-solving skills.
* Ability to take ownership of her/his responsibilities.
* Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Globus Medical is an Equal Opportunity Employer. EOE M/F/D/V
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