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Department: Regulatory Affairs - 067
Schedule: Full Time
Shift: Days
Hours: 8am-5pm
Salary Range: Grade 21 - $115,000-$140,000+bonus
Job Details:
  • Bachelors of Science
  • POSITION SUMMARY:

    ·         Leads a team of regulatory professionals, interacts with personnel in scientific, technical and/or marketing areas, and collaborates with peers and management to effectively accomplish company goals and objectives.

    ·         Ensures company compliance with the regulatory requirements related to 21 CFR Parts 820 and 1271, European medical device and tissue directives and U.S and international pre-market submission/registration requirements for all classes of devices/tissues.

    ·         Maintains and applies current knowledge of applicable medical device and tissue regulations and standards, provides information and guidance to management and personnel in other areas as needed. 

    ·         Develops and communicates strategy on the most timely and cost effective path to market clearance for regulatory submissions.

    ·         Prepares, reviews, provides guidance and/or approves regulatory submissions to US and international regulatory agencies, ensuring accuracy, completeness, consistency, clarity and effective communication.

    ·         Represents the company at industry meetings and conferences, including participation on committees and task forces. 

    ·          Manages relationships with FDA and domestic/international “customers” (e.g., regulatory agencies, distributors, healthcare facilities).

    EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately)

    ·         Bachelor’s Degree required, preferably in a science or technical discipline.

    ·         Minimum 7 years direct experience in Regulatory Affairs within a medical device or biologics company, including PMA experience, required.  Previous experience in clinical laboratory preferred.

    ·         Minimum of 5 years supervisory or management experience required.

    ·         Knowledge of FDA 21 CFR Part 820 and ISO 13485 required.  Familiarity with 21 CFR Part 1271 and AATB standards preferred.

    ·         Experience with databases and Microsoft Office Suite including Excel required

    KNOWLEDGE, SKILLS AND ABILITIES: (list required and preferred separately)

    ·         Strong interpersonal, organizational, problem-solving and verbal/written communication skills, especially technical writing, required.  

    ·         Ability to think/plan strategically while handling details with accuracy required.

    ·         Willingness to travel approximately 20% of the time required.

    This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety glasses.

     

    List activity requirements and percentage of time:  KEY:  Not at all (0%), Occasional (1-33%),  Frequent (34-66%), Constant (67-100%)

     

    Climbing:   Not at all (0%)                      Bending: Occasional (1-33%)                         Kneeling/Crawling with force:   Not at all (0%)                    

    Pulling: Occasional (1-33%)               Reaching Above Head: Occasional (1-33%) Twisting at waist: Occasional (1-33%)

    Lift above shoulders: Occasional (1-33%)                                                                       Lift from floor level: Occasional (1-33%)         

     

    Physical Requirements:

    Sedentary work: Prolonged periods of sitting & physically handle objects up to 10 lbs occasionally.

    Stand for   3 hours/day         Sit for 8 hours/day                Perform repetitive tasks/motions    Have good manual dexterity          

    Have good eye/hand/foot coordination                        Hear alarms/telephone/normal voice             Have Clarity of Vision                     

    Near Acuity (Clarity of vision at 20 inches or less)      Far Acuity (Clarity of vision at 20 feet or more)             Distinguish colors

     WORKING CONDITIONS: Biomedical manufacturing environment.  Potential hazards include exposure to:

    Hazardous chemicals: Not at all (0%)                                               Blood or body fluids: Not at all (0%)

    Extreme conditions, hot or cold: Not at all (0%)                              Communicable diseases: Not at all (0%)

    Saw Blades, needles or other sharp objects: Not at all (0%)          Unprotected heights: Not at all (0%)

    Moving mechanical parts: Not at all (0%)                                         Latex exposure: Not at all (0%)         

     

  • EOE/M/F/Vets/Disabled
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