Staff Regulatory Affairs Specialist

BD; Poland; Hybrid; PLN 452,000 - 748,000; Full time

Job summary

A leading global medical technology company in Poland is seeking a Regulatory Affairs professional to ensure compliance and support regulatory processes. The ideal candidate has at least 5 years of experience in Regulatory Affairs within the medical devices sector and holds a relevant bachelor’s degree. This role offers a competitive salary ranging from $124,700 to $205,807 annually and requires on-site collaboration for most roles.

Qualifications

• 5+ years of strong Regulatory Affairs/Compliance experience in medical devices.
• Knowledge of global Regulatory Affairs requirements, regulations, and standards.
• Experience with end-to-end SaMD new product development.

Responsibilities

• Support regulatory effort to comply with new and existing regulations.
• Drive continuous improvement in internal processes.
• Assist in preparing, auditing, and publishing registration documentation.

Skills

Regulatory Affairs

Compliance

Problem-solving

Interpersonal skills

Communication

Analytical skills

Education

Bachelor’s degree in RA, QA, engineering, or related discipline

Advanced degree (e.g. MS, Life Sciences)

RAPS RAC certification

Job description

Overview

We are the makers of possible.

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Primary Responsibilities

• Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)

• Problem solve and escalate regulatory and compliance issues to senior management as necessary

• Drive continuous improvement in internal processes and customer satisfaction

• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW

• Support that QMS requirements are followed and executed consistently from RA perspective

• Support efforts for Technical File creation, remediation, and collaboration with cross-functional teams for required content

• Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level

• Assist in preparing, auditing, editing, and publishing registration documentation as needed

• Support business export control (BEC) listing of product for release globally per RA requirements

• Support the review and approval of product labeling, promotional, and advertising materials as needed

About You

• Minimum bachelor’s degree in RA, QA, engineering, or other science-related discipline

• Advanced degree (e.g. MS, Life Sciences) preferred

• RAPS RAC certification preferred

• Minimum of 5 years of strong Regulatory Affairs/Compliance experience in medical devices

• Experience with end-to-end SaMD new product development, sustaining and end of life activities including experience on new labeling creation (including inputs on labeling specifications), risk management file review and inputs (including all documents required under risk files).

• Knowledge of global Regulatory Affairs requirements, regulations, and standards

• Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects

• Excellent interpersonal, communication, and analytical skills and able to partner with cross-functional colleagues to identify regulatory innovation

Salary and Work Arrangements

Salary ranges range from USD 124,700.00 to 205,807.00 annual, depending on experience, education, skills, and location. Salaries may vary for field-based and remote roles. On-site collaboration is prioritized to foster creativity and problem-solving; a minimum of 4 days in the office per week is expected for most roles, with flexibility where applicable. Remote or field-based positions will have different workplace arrangements indicated in the job posting.

For certain roles at BD, employment is contingent upon proof of full COVID-19 vaccination where required by location. Testing may be available or required in some locations. Requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. It’s a place to do what’s right, be accountable, and learn and improve every day. BD is committed to helping you grow and thrive while making a meaningful impact in health.

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.