Regulatory Affairs Specialist
Proclinical is urgently recruiting for a remote Regulatory Affairs Specialist for a global medical device company. As the RA Specialist, you will gather and research the necessary information for inclusion into product applications. Write 501(k)'s IDE'S, PMA'S and follow up with FDA to ensure clearances / approval. Incumbent will resolve regulatory issues and develop solutions to a variety of problems of moderate scope and complexity.
- Develops regulatory strategies for product registration to ensure early product approval.
- Keeps abreast of FDA events and competitive products.
- Lists products with the FDA listing Branch. Responds to FDA inquiries regarding product listings.
- Participates in the development, review and approval of product labeling.
- Reads legal documents and federal regulations and interprets essential elements
- Audits regulatory records and reports.
- Communicates through written and oral means; in face to face contact, meetings and phone discussions.
- Writes technical documents.
- Supports post-market activities required to launch new products (eg, load sheets)
- Review and approve advertising and promotional items to ensure regulatory compliance.
- Assimilates information from a variety of sources and organize information into a logical, presentable format.
- Works under minimal supervision, with benefit of previous regulatory experience.
- Reads drawings/blueprints.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
Skills and Requirements:
- Bachelor's degree in life sciences or related field, preferred with 5-7 years' experience or a minimum of 12 years equivalent work experience in the Regulatory environment.
- Experience authoring a minimum of ten (10) documents/submissions or equivalent experience
- Professional certification(s) highly desirable (RAC Certification)
- Knowledge of US Medical Device law, Quality Systems Regulations and compliance.
- Able to analyze and develop strategies for regulatory submission with minimal supervision.
- PC experience is required and proficiency in Office, Adobe, SAP, etc.
- Requires strong written, oral, interpersonal, group, and telephone communication skills.
- Must be detail-oriented and highly organized.
- Analytical skills needed to conduct research, analyze data and write recommendations.
- Some domestic and international travel is required.
- Organizes work and juggles multiply priorities; organize thought processes.
- Ability to work and problem solve both independently and within a team.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.