Essential responsibilities include but are not limited to:
- Adhere to all company policies, procedures and comply with all safety & regulatory requirements;
- Monitor and measure metrics and present relevant data to the management;
- Ability to recognize issues and develop solutions for continuous improvement.
Regulatory Affairs Associate/Specialist
- Coordinate efforts associated with the preparation of regulatory documents or submissions;
- Coordinate, prepare, or review regulatory submissions for domestic or international projects;
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance;
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures;
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents;
- Recommend changes to company procedures in response to changes in regulations or standards;
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies;
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review;
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues;
- Compile and maintain regulatory documentation databases or systems;
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes;
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies;
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation;
- Review study protocols to ensure appropriate collection of data needed for regulatory submissions;
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Authorization to work in the US for any employer without requiring further sponsorship.
- A minimum of Bachelor’s in Regulatory Science, Life Sciences, Medical Technology.
- Minimum of 2 experience in a regulated medical device environment.
- Keen attention to details; ability to write clear and concise text for regulatory submissions SOPs and other technical documentation;
- Timeline/Deadline driven work ethic;
- Demonstrated ability to work efficiently independently; as well as in a team-based environment to organize & manage projects with multiple priorities; and assigned tasks;
- Effective team player and ability to collaborate with cross functional teams;
- Proactive, planning and exhibits high level of critical thinking abilities;
- Strong verbal and written communication skills;
- Enthusiastic demeanor with a can-do attitude;
- Proficiency in MS office (Word, Excel, PowerPoint and other applications
Women and Minorities are encouraged to apply.
Diversity is foundational to PerkinElmer and we know that hiring talent with different backgrounds will provide a greater impact for our customers and a more inclusive workplace for our team. Our commitment to creating a culturally diverse workplace is REAL! We know that it’s the people that make PerkinElmer a wonderful, enriching place to work that is why we are always searching for talented and motivated individuals to join the PerkinElmer Family.
So what’s in it for you?
We create a customized development plan to help you achieve your career goals. We partner with you to build a long and rewarding career by providing:
- On-the-job training
- Mentoring relationships
- Ongoing career development planning
- Company and external training programs
- Opportunities for internal career mobility
Our company fosters innovation, knowledge sharing, and teamwork for long-term success. We are committed to the development of your career, giving you opportunities to learn and grow. Simply put, we make a difference for you, so you can make a difference in the world.
We are passionate about our work and the benefits we create for our customers, our communities, and our environment. Every day, we help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
With about 13,000 employees worldwide, we pioneer scientific technologies for food and drug safety, environmental monitoring, industrial analysis, screening and diagnostic testing, and imaging for life sciences. We provide better detection, imaging, and informatics to help our customers make a profound impact on the world.