Piper Companies has an immediate need for a Sr. Regulatory Affairs consultant at a large Medical Device company in Somerville, NJ. Please send resumes to email@example.com for consideration.
Sr. Regulatory Affairs Consultant Project :
The Senior Regulatory Affairs consultant will be supporting a multi-year consulting assignment with the Regulatory Affairs department supporting 2 NPD project initiatives within the Open Would/Closure.
- The 1st project is supporting 2 new key products and regulatory submissions related. There is a suture technology (expecting 3-4 510Ks in 2020) and a new topical cream (there is a new design concept expected in the new year) on the product portfolio).
- The 2nd project support is related to EUMDR and assisting with regulation compliance/submissions.
- Submissions will mostly be related to US/EU but a few other markets are China, Japan, Brazil, Australia.
The Senior Regulatory Affairs Specialist will execute the Regulatory Affairs platform strategy. We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as life-cycle product registrations.
In This Role, You Will
- Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches and related regulatory activities.
- Complete the preparation and submission of regulatory information required to obtain global market access, identifying risk and issues, effectively communicating timelines for project completion, and addressing issues that may impact registration status.
- Execute on plans that directly impact the operational results.
- Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling Center of Excellence, as well as global Regulatory Affairs affiliates
- A minimum of a B.A. /B.S. within a technical related discipline is required
- A minimum of 6 years relevant / regulated industry overall experience is required
- A minimum of 2 years of medical device regulatory experience is required.
- A demonstrated track record of developing and executing global regulatory strategies that align with business deliverable is preferred
- Working knowledge and thorough understanding of how global regulations impact product registration is required
- Strong written & verbal communication and presentation skills is required
- Collaborative work style in a highly matrixed environment is required
- The ability to build and sustain productive partnerships across multiple platforms is required
- The ability to evaluate new regulatory requirements as well as regulatory changes, and correctly assess business impact is preferred
- Plan and execute complex projects through timely completion is required
Mia N. Rogari
Sr. Account Manager I Piper Companies -Life Sciences
1001 E. Hector Street. Suite 205. Conshohocken, PA 19428
Office: (610) 347-9657 | Cell: (570) 472-1605
firstname.lastname@example.org | www.pipercompanies.com |LinkedIn