RAQA Specialist - Medical Device Job at Professional Alternatives, Sugar Land, TX

L01UOCtvTFZnbDVGV3RHSVhlS21UaVlISnc9PQ==
  • Professional Alternatives
  • Sugar Land, TX

Job Description

Job ID#: 26891

RAQA Specialist – Medical Device industry
Direct Hire; up to 80K
Sugar Land

Duties:

  • Research and provide recommendations to product teams on appropriate regulatory pathways to market
  • Participate in teams to ensure appropriate global regulatory requirements are incorporated as part of development and design change process for both new and existing products
  • Research, author, or provide support for regulatory
  • Coordinate with Notified Bodies, Competent Authorities, and other regulatory agencies on  submissions, audits, approvals, or other issues
  • Interpret existing and/or new regulatory requirements relating to products and procedures; communicate to personnel
  • Provide marketing and literature review pre and post market
  • Research, author, or provide support in preparation and updates to Technical Files
  • Assist with development, implementation, and maintenance of regulatory SOP’s and development/improvement of processes and procedures
  • Participate in RA related parts in site audits and routine RA maintenance activities

Qualifications:

  • High school diploma required; some college and work experience
  • Experience in regulatory affairs/quality assurance/product development and processes in the medical device industry; regulatory audits and inspections
  • International regulations and standards (CFR, MDD, MDR, QSR, ISO 13485, MDSAP, etc.)
  • USA (federal, state, and local) and International product registrations (CFG’s, apostille, and consularization processes); medical device import and export requirements
  • Technical writing and creating reports, SOPs, etc.; strong Microsoft Office Suite
  • Organized, analytical, keen eye for detail, strong communication, business acumen,
  • Team player, collaborative, and positive approach; independent, self-starter

Other Info:

  • Business casual attire
  • Thriving and growing organization recently involved in acquisitions; 160 team members
  • Well-rounded benefits package
  • Amazing company culture – collaborative, fun, down to earth, engaging, and approachable and motivating senior leadership
  • Some travel may be required

Founded in 1998, Professional Alternatives is an award-winning recruiting and that utilizes technology and relationships to deliver top talent.  Connect with us today!

Job Tags

Work experience placement, Casual work, Local area,

Similar Jobs

Kamehachi

Sushi Chef Job at Kamehachi

 ...Kamehachi in Northbrook is looking to fill a Sushi Chef position with at least 2 years of experience Our ideal candidate must have a passion for cooking especially Japanese food. You must have great communication skills and have a professional approach to the position... 

ABC Animal Hospital

Veterinary Assistant Job at ABC Animal Hospital

 ...ABC Animal Hospital is hiring a full-time Assistant Veterinary Technician for our Suisun City location. **Must have weekend availability,...  ...diploma or general education degree (GED); or one-year related experience and/or training; or equivalent combination of education and... 

Boston Scientific

Principal Medical Education Specialist Job at Boston Scientific

 ...high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information...  ...s transseptal access technologies to support product education and skills training for Health Care Professionals (HCPs). Identify... 

Belfast Hotel

Laundry Worker Job at Belfast Hotel

 ...Responsibilities: Load all laundry into the washer and add specified cleaning agents according to directions Inspect laundry equipment...  ...and report any maintenance issues to the building management Dry clothing and linens after each wash cycle according to the... 

Jules Hendrix

HR Professionals | Recruiting Specialists - Fully Remote Career Change Job at Jules Hendrix

 ...HR Professionals | Recruiting Specialists | Fully Remote Career Change Option About The Opportunity: Are you an HR Professional or Recruiting Specialist looking for a different career that offers more flexibility, financial growth, and greater personal fulfillment...