Regulatory Operations Specialist
Bioventusa day ago
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OnsiteFull-timeEntry
Summary
Bioventus is seeking a Regulatory Operations Specialist to join their team in Durham, NC. The role involves providing hands-on regulatory affairs support for new product marketing approvals and renewals for existing products.
About the Role
As a Regulatory Operations Specialist, you will support various applications to receive product clearance and maintain existing registrations globally. Your responsibilities will include maintaining Technical Files compliant with regulations, coordinating legalization of regulatory documents, and communicating with regulatory agencies. You will also support internal and external audits and perform regulatory assessments for design and manufacturing changes.
About You
Required:
- Bachelor’s Degree in Life Sciences, Engineering or other related discipline.
- 1-2 years of experience in Regulatory Affairs, preferably in the medical device industry.
- General understanding of US and EU regulatory requirements.
- Familiarity with SAP and GTS module.
Preferred:
- Experience with FDA, EU, Health Canada, Brazil, Japan, and Australia registration.
- Excellent communication skills, both oral and written.
- Detail-oriented with considerable organizational skills.
Benefits
- Opportunity for career growth and hands-on experience in regulatory affairs.
- Inclusive and diverse work environment.
Bioventus
Bioventus®Inc. (Nasdaq: BVS) develops Innovations for Active Healing and its mission is to make a difference by helping patients resume and enjoy active lives. The Company has products focused in three vertical markets: pain treatment, restorative therapies and surgical solutions. Established in 2012, Bioventus is headquartered in Durham, NC. The company has more than 1,200 employees worldwide and its international headquarters is in Hoofddorp, The Netherlands. Bioventus also has offices in Memphis, TN, Farmingdale, NY, Valencia, CA and Mississauga, Ontario, Canada. Bioventus works with patients, payers and health care providers throughout the world. Visit www.Bioventus.com and find us on Twitter @bioventusglobal.
Durham, NC