Kelly Services is looking for a Regulatory Affairs Associate in North Haven, CT
This is a 12 month contract
SUMMARY OF POSITION:
The Regulatory Affairs Associate is responsible for assistance with management of the Regulatory Affairs department activities, supporting US FDA and EU submissions and the support in managing international regulatory registrations with the Regional Business Units (RBU), which includes global regulatory strategies and impact assessments, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.
• Collaborate and support RBUs to determine local regulatory pathways, requirements and timelines.
• Collaborate and support RBUs by providing the documentation necessary to prepare their local regulatory submissions. Including, but not limited to obtaining Certificates to Foreign Government, Letter of Authorization, technical reports, and the notarization of documents.
• Collaborate and support RBUs in coordinating international regulatory activities on behalf of the Surgical Innovations business.
• Ensure the timely and accurate filing of regulatory documentation.
• Develop and maintain product technical files.
• Maintain product licenses by providing annual notifications as required by specific regions.
• Assist in the development, documentation, and implementation of regulatory strategies for product modifications and manufacturing production line transfers to include applicable international requirements.
• Provide regulatory affairs support to design and change control teams to assess regulatory impact of design changes including and manufacturing production line transfers.
• Actively maintains and reports registration status with applicable registration trackers and applications.
• Perform other regulatory affairs duties when requested.
• Interface with quality, operations, clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
• Ensures rapid and timely responses to requests from regulatory agencies and third party registrars
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
• Performs other duties and responsibilities, as required.
Education required: - Bachelor’s degree in a scientific or engineering field
Experience: - 2+ years related experience in a technical job function/role
Preferred Skills/Qualifications: - Experience in a regulated industry, preferably medical devices, with an emphasis in regulatory or quality assurance
• Excellent verbal and written communication skills
• Experience using electronic filing systems, and/or databases
• Ability to interface effectively with individuals from a wide variety of disciplines to research and obtain appropriate documentation for the submission of regulatory information.
• Ability to prepare and submit regulatory documentation packages.
• Have the basic knowledgeable with international regulations
• Ability to interface effectively with international individuals to support global registrations
Skills/Competencies: - High Level of proficiency using MS Excel and MS Word.
• Working knowledge of MS Access, MS Project, MS InfoPath and Adobe Acrobat Pro.
• High learning aptitude and adaptability with software systems
• Demonstrated technical writing skills
Other Skills: - Multi-tasks and prioritizes effectively in fast-paced environment
• Highly organized, detail oriented, and efficient
• Highly self-motivated
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
• Demonstrated leadership qualities
• Ability to manage small scale projects to completion within and outside of the direct department
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within in the regulatory landscape
• Works directly with the Manager of Regulatory affairs on FDA, TUV notify body and international regulatory matters when required.
• Works with supervisors and managers during the course of registration preparation.
• Works with state personnel and foreign consulates/embassies personnel as appropriate.
• Works with project team members and other company personnel as required.
• Communicates with FDA and TUV notify body regarding status of regulatory submissions and other regulatory matters.
There will be no OT.
Top three must haves:
• Bachelor’s degree in a science field
• Motivational and interpersonal skills
• Superb time management and organizational skills
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.