Senior Regulatory Affairs Specialist
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Regulatory Affairs Specialist in Valencia, California. The Senior Regulatory Affairs Specialist will apply regulatory expertise to the evaluation and solution of product development issues. They will oversee the
content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities
- Draft or compile supporting documentation related to such applications and manage any related activities by third parties
- Interface with clinical research organizations or in-house clinical research associates in drafting or assembling regulatory materials
- Lead regulatory compliance activities on UDI requirements and regulations for Class II, Class I and 510 (k) exempt products
- Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests
- May interface directly with outside counsel and governmental regulatory personnel, including scientific reviewers, administrative staff, and management, to facilitate the review and approval of regulatory applications
- Represent Regulatory Affairs on assigned project teams through all phases of product development
- Communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues
- Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis, risk assessment reviews, timeline development and reviews, and V & V reviews
- Actively reviews and edits documents associated with product development meetings
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change
- Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines
- Review and interpret scientific literature and summarize effectively in writing
- Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends
- Ensure training and compliance with global quality system regulations
- A minimum of five years of experience in the medical device industry, preferably in a small manufacturing or R&D environment that includes medical writing, clinical studies, regulatory submissions, and regulatory reviews
- Must have experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)'s and CE Submissions
- Ability to independently analyze and interpret novel clinical, medical and scientific data
- Current knowledge of current U.S. FDA and global (Canada, Australia, European Union, Latin America, India, China, etc.) regulatory requirements within the medical device industry
- Good knowledge of MS Office, Internet, databases, etc
- Excellent writing skills and the ability to write scientific summaries.
- BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.