Remote Regulatory Affairs Senior Specialist

Job description

Kelly Science & Clinical is currently seeking a Remote Regulatory Affairs Senior Specialist for a long-term engagement with one of our Global Med Device clients out of Raynham, MA

***This role is fully remote***

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Responsibilities
Act as RA lead on new product development and multi-platform LCM projects with varying complexities.
Support project teams by defining regulatory requirements to achieve compliance.
Work with project team to identify and address critical path or roadblock issues.
Create robust global regulatory strategies. Ensure changes are effectively communicated to global partners for registration impact.
Ensure project plans and deliverables are compliant with appropriate design control procedures and other global regulation requirements as applicable.
Compiles regulatory submissions (Type C meetings, IND, 510(k), filing amendments and correspondence with US and EU regulatory authorities.
Support International team with product re-registration.
Communicate effectively with Management.
Participates in process improvement and corporate initiatives as appropriate.
Maintains knowledge of current applicable regulations and guidance documents.
Maintains the highest levels of professionalism, ethics, and compliance always.

Qualifications
A minimum BA/BS Degree with at least a total of 8 years of regulated drug and medical device industry experience (or related) and at least 3 years of direct experience in regulatory affairs function
Knowledge of U.S. FDA drug and medical device regulations and guidances is required
Knowledge of EU MDD & MDR medical device regulations and guidances is required
Knowledge of U.S. FDA combination product regulations and guidance's a plus
IND submission experience is required
CMC regulatory experience is a plus
Experience with orthopedic implants a plus
Familiarity with international medical device regulations and guidance (such as China, Brazil, Japan, etc.) a plus
Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part.
Familiarity with electronic submission preparation a plus
Excellent written and oral communication skills
Ability to handle multiple tasks and be detail oriented

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.