Regulatory Affairs Specialist (Innovation)
BD —Sparks, MD
- $95,900 - $153,400 a year
- Microsoft Excel
- 5 years
- Mid-level
Exercise Specialist
LA Fitness —Nottingham, MD
- Up to $65,000 a year
- Part-time
- Mid-level
- Bachelor's degree
- Fair chance
- Health insurance
- Employee discount
Quick Apply
14d
Assistant Sports Performance Coach
University of Maryland Baltimore County —Baltimore, MD
- $55,000 - $62,000 a year
- Full-time
- Background check
- CPR Certification
- Mid-level
- Disability insurance
Fitness Center Manager - Pikesville, MD
The National Institute for Fitness and Sport (NIFS) —Pikesville, MD
- $48,000 - $55,000 a year
- Full-time
- Background check
- CPR Certification
- Pass drug screening
- Paid time off
Quick Apply
Intake Specialist, Rehabilitation and Recovery
Sheppard Pratt —Timonium, MD
- $21.37 an hour
- Monday to Friday
- High school
- High school diploma or GED
- Driver's License
- 403(b) matching
- Mileage reimbursement
Quick Apply
Fitness Specialist - Baltimore, MD
FOX Rehabilitation —Nottingham, MD
- $21.00 - $26.75 an hour
- Part-time
- CPR Certification
- Ability to walk for extended periods
- BLS Certification
- Wellness program
13d
Substitute Health Fitness Specialist - Towson, MD
The National Institute for Fitness and Sport (NIFS) —Towson, MD
- $18 - $20 an hour
- Full-time
- Background check
- CPR Certification
- Customer service
Quick Apply
Call Center Specialist
Healthcare For the Homeless Inc —Baltimore, MD
- $17.50 - $20.00 an hour
- Full-time
- Spanish
- HIPAA
- High school diploma or GED
Quick Apply
Clinical Exercise Physiologist - Team Leader
MedStar Health —Baltimore, MD
- $25.86 - $46.12 an hour
- Full-time
- Hospital
- Mid-level
- Outpatient experience
13d
Personal Trainer
Crunch Fitness - Fitness Growth Capital —Westminster, MD
- $27 - $32 an hour
- Weekends as needed
- CPR Certification
- Residential
- High school diploma or GED
Quick Apply
Personal Training Manager
Crunch Fitness - Fitness Growth Capital —Westminster, MD
- $50,000 a year
- Full-time
- CPR Certification
- Customer service
- Mid-level
- Paid training
- Paid time off
Quick Apply
Recreation Specialist - Druid Hill
The Y In Central Maryland —Baltimore, MD
- $15.50 an hour
- Part-time
- Customer service
- Ability to walk for extended periods
- No experience needed
- Health insurance
- Dental insurance
Quick Apply
Client Service Specialist
Healthcare For the Homeless Inc —Baltimore, MD
- $36,667 - $41,556 a year
- Online Application
- Spanish
- Writing skills
- Data analysis skills
- Continuing education credits
- Paid parental leave
Quick Apply
Benefits Specialist (Application Counselor) 6:30am-3pm
HealthCare Access Maryland —Baltimore, MD
- $22.29 an hour
- HIPAA
- Mid-level
- High school diploma or GED
- Health savings account
- Disability insurance
Quick Apply
Personal Trainer - Stretch & Recovery Specialist
Onelife —Parkville, MD
- Part-time
- CPR Certification
- Mid-level
- High school diploma or GED
- Health insurance
- Dental insurance
6d
Clinical Exercise Physiologist - PRN
MedStar Health —Baltimore, MD
- $22.48 - $39.75 an hour
- PRN
- Hospital
- Mid-level
- Master's degree
Recreation Specialist - Waverly (Weinberg)
The Y In Central Maryland —Baltimore, MD
- $15.50 an hour
- Part-time
- Customer service
- Ability to walk for extended periods
- No experience needed
- Health insurance
- Dental insurance
Quick Apply
6d
Contractor-Fitness Instructor, Office on Aging and Independence
Howard County —Ellicott City, MD
- Contract
- Background check
- CPR Certification
- Pass drug screening
Substitute Health Fitness Specialist - Baltimore, MD
The National Institute for Fitness and Sport (NIFS) —Baltimore, MD
- $18 - $20 an hour
- Per diem
- Background check
- CPR Certification
- Customer service
Quick Apply
PRN Injury Prevention Specialist
ATI Physical Therapy —Middle River, MD
- $25 - $35 an hour
- Full-time
- Military
- BLS Certification
- Master's degree
- Wellness program
- Continuing education credits

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exercise specialist jobs near hunt valley, md

Regulatory Affairs Specialist (Innovation)

BD -
Sparks, MD

Apply Now

Job Details

$95,900 - $153,400 a year

Qualifications

Optimizing workflow processes
FDA submissions
Microsoft Excel
5 years
Bachelor's degree in biomedical engineering
Biomedical Engineering
Mid-level
Schedule management
Collaboration with product development teams
Policy & process development
Bachelor's degree
Compliance documentation
CLIA regulations
Organizational skills
Pharmacy
Regulatory submission editing and review
Biomedical regulatory compliance
Managing projects
Productivity software
Quality systems
Regulatory compliance analysis
Medical affairs
Standard operating procedures (SOPs)
Project risk management
Continuous process improvement (CPI)
Communication skills
ISO 13485
Negotiation
Cross-functional communication
Documentation reviews

Full Job Description

Now

Job ID

R-547486

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.

Responsibilities:

Serves as Regulatory Affairs SME on various new product development (NPD) teams
Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
Recognizes and addresses potential regulatory risks with project plans
Responsible for organizing and leading various FDA & EU IVDR submissions
Serves as contact to FDA and Notified Body review teams during submission reviews/communication
Recognizes and proposes continuous process improvements.

Required Education and Experience:

Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
Minimum 5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)

Preferred Skills and Experience:

RAPS Certification preferred
Demonstrated experience in interpreting subjective and complex aspects of specific regulations
Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions

Skills

Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.

Technical & Functional:

Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
Understanding of regulatory submission processes and lifecycle management

Communication & Collaboration:

Strong written and verbal communication skills
Experience working with cross-functional, fast-moving teams
Confidence in speaking up within cross-functional teams when regulatory risks are present

Process & Compliance:

Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
Ability to identify and support process improvements

Other:

Strong organizational skills and ability to manage multiple submissions/projects simultaneously
Adaptability to changing timelines and priorities
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
Remote opportunity for the right individual

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$95,900.00 - $153,400.00 USD Annual

Apply Now

Refine Your Search

exercise specialist jobs in hunt valley, md

Regulatory Affairs Specialist (Innovation)

Exercise Specialist

Assistant Sports Performance Coach

Fitness Center Manager - Pikesville, MD

Intake Specialist, Rehabilitation and Recovery

Fitness Specialist - Baltimore, MD

Substitute Health Fitness Specialist - Towson, MD

Call Center Specialist

Clinical Exercise Physiologist - Team Leader

Personal Trainer

Personal Training Manager

Recreation Specialist - Druid Hill

Client Service Specialist

Benefits Specialist (Application Counselor) 6:30am-3pm

Personal Trainer - Stretch & Recovery Specialist

Clinical Exercise Physiologist - PRN

Recreation Specialist - Waverly (Weinberg)

Contractor-Fitness Instructor, Office on Aging and Independence

Substitute Health Fitness Specialist - Baltimore, MD

PRN Injury Prevention Specialist

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